Alzheimer's Disease-Clinical Trials-Part XX
The following is a list of Web sites that offer information on taking part in clinical trials, some of which are of particularly involved with older individuals:
www.cdc.gov/hiv/pubs/brochure/unc3bro.htm-Contains a list of questions to ask when considering taking part in a study, compiled by the Centers for Disease Control and Prevention.
www.clinicaltrials.gov -Contains over 8,200 clinical studies sponsored by the National Institutes of Health, other federal agencies and the pharmaceutical industry.
www.centerwatch.com -Lists more than 41,000 trials, mainly those being done by the pharmaceutical industry.
www.alzheimers.org -Click on "clinical trials" in the left-hand column to go to the Alzheimer's Disease Clinical Trials Database, a joint project of the FDA and the National Institute on Aging.
www.cancer.gov/clinicaltrials -Click on "finding clinical trials" to access the National Cancer Institute's database of studies, along with links to sources.
(4/12/13)- The conclusion of a study of the cost of dementia conducted by the Rand Corporation was that it was costing between $157 billion and $215 billion a year in medical care and other costs, such as lost wages for caregivers.
The results of the study were published in a recent edition of the New England Journal of Medicine. The researchers examined a group of more than 10,000 adults age 71 and older who were enrolled in a large national representative study called the Health and Retirement Study. It was estimated that 14.7% of those in the sample were afflicted with dementia.
The Alzheimer Association estimates that there are presently 5.4 million American who are suffering from this malady.
The direct medical cost of treating dementia is estimated at $109 billion in 2010, compared to $102 billion for those who suffer from heart disease and $72 billion for those with cancer.
(2/7/13)- According to the U.S. National Institutes of Health's ClinicalTrials.gov website, there are currently 139,372 clinical studies being conducted throughout 182 countries as of Jan. 28, 2013.
The number of registered clinical studies has increased by an average of 28% annually since the year 2000. According to Pharmaceutical Research Manufacturers of America, the pharmaceutical companies lobbying organization, $49 billion was spent last year on researching more than 2,900 compounds.
(5/21/12)- Can Alzheimer's Disease be prevented before it takes its dreaded toll? A $100 million trial, funded by a combination of the federal government, academic researchers, charitable foundations and the drug maker Genentech Inc., which is a subsidiary of Roche Holding AG are going to try and find out.
The drug that will be used for the test is an injectable one named crenezumab. The drug is currently being tested in two clinical trials in this country, Canada and western Europe with people with mild to moderate symptoms to see if it can reduce cognitive decline or amyloid accumulation, with Genentech sponsoring these studies.
The trial will be financed with $16 million form the National Institutes of Health, $15 million from private donors through the Banner Institute and about $65 million from Genentech.
It is hoped that crenezumab will help to break up the clustering of amyloid plaques in the brain. It has not been found to have any negative effects on the brain.
About 300 of the participants in the study will come from Medelin, Columbia because they come from an extended family with a specific genetic mutation, so that they begin to show signs of the disease at 45, and full dementia at 51.
The drug trial is part of the federal government's first national plan to address Alzheimer's Disease (The National Plan to Address Alzheimer's Disease), and it was unveiled by Kathleen Sebelius, the secretary for health and human services.
The trial will start in 2013, and the patients will be treated for up to 5 years.
The NIH also made a $7.9 million grant for a study testing the effectiveness of an insulin spray in treating patients in the early stages of the disease.
(9/14/10)- A recent email from one of our readers asked the question about the essential steps in a medical (clinical) evaluation. We consulted the Centers for Disease Control and Prevention Toolkit for Health Care Professionals and came up with the following:
A detailed patient history, including a review of medications.
A thorough physical examination.
A mental status screening.
A minimum battery of laboratory screening tests including:
Alanine aminotranferase or aspartate transaminase serum level.
Albumin and rheumatoid factor.
Blood urea nitrogen.
Complete blood count with leukocyte differential.
Thyroid function tests.
Other test may be included if the treating physician is looking for specific factors in arriving at a differential diagnosis
(8/26/10)- Eli Lilly & Co. announced that it was halting development of its experimental Alzheimer's disease drug semagacestat, after studies showed it was worsening the patients' conditions, and was associated with an increased risk of skin cancer.
Lilly has another experimental AD drug candidate, solanezumab, in late stage development that is not affected by this decision,
Thus, although the news recently concerned being able to determine whether or not an individual is going to be afflicted with the disease through a spinal tap, the battle to find a cure for the disease continues to baffle the scientific community
Semagacestat is a gamma secretase inhibitor that was designed to work by blocking an enzyme in the brain that causes the formation of amyloid plaque. It was designed to deal with patients who had mild-to-moderate Alzheimer's
The interim analysis found that cognition and ability to complete daily activities in patients taking the drug worsened to a greater degree than those taking a placebo. The patients taking semagacestat also had a higher rate of skin cancer.
(7/25/10)-In a study conducted by researchers at the Massachusetts Institute of Technology, that was funded by an American Parkinson Disease Association fellowship and grants from the National Institutes of Health and the Paul E. Glenn Foundation, which backs research on the biology of aging, it was shown that by working on the gene, SIRT1, in the brains of mice, it was possible to reduce their erosion of memory and learning ability.
The gene.regulates the production of a class of proteins known as sirtuin 1. Mice with a model of Alzheimer's disease that were genetically engineered to produce more sirtuin 1 retained both memory and learning ability as they aged
Mice without the enhanced sirtuin capability, and those engineered to produce no sirtuin 1 at all, showed steep declines in learning ability and memory as they aged. SIRT1 has been described at the "longevity gene". Studies have shown that a highly calorie-restricted diet can turn on the gene and thereby increase longevity in everything from yeast to mice
The question remains however as to whether or not there is a connection between SIRT1 and Alzheimer's disease
(6/13/10)- In attempting a new approach at getting to the bottom of Alzheimer's disease, 5 of the major drug companies have agreed to pool their data as to the results of their failed clinical trials. Data from 4,000 patients involved in 11 failed AD clinical trials are now publicly available for all to see.
The drug companies involved in this project are Johnson & Johnson, GlaxoSmithKline PLC, Astra-Zeneca PLC, Sanofi-Aventis and Abbott Laboratories.
The coalition intends to create a similar pooled database for Parkinson's disease and tuberculosis in the future.
FDA Deputy Commissioner Joshua Sharfstein said, "I think the FDA recognizes that one thing that can accelerate drug development is sharing information that is relevant to a disease."
(10/27/08)-A biomarker is a term for something present in the body which can indicate disease, such as a certain protein or molecule. The Nottingham team will be identifying biomarkers by looking at proteins in the blood of Alzheimer's patients compared to a control group of healthy older people.
The researchers at The University of Nottingham hit upon the idea of using biomarkers as a means of diagnosis and will be involved in collecting the samples in conjunction with collaborators in the UK and EU, while the samples will be tested using technology based at Nottingham Trent University.
Researchers from Nottingham's two universities are joining forces to develop a simple blood test to diagnose Alzheimer's disease. The Ł200,000 study, funded by the leading charity the Alzheimer's Research Trust, will aim to find out whether 'biomarkers' in blood could be used to identify someone with Alzheimer's.
(6/22/08) Would you bet on a drug that has a thirty percent chance of reaching the market? Apparently, many stock investors had this idea on Tuesday, June 17, when the stock of the pharmaceutical company, Wyeth, rose 4.83 percent on a potential product for treating Alzheimer’s disease. The drug is bapineuzumab, "one of 23 paths that Wyeth is exploring under its so-called war on Alzheimer’s" (NY Times June 18, C2). Phase 3 stage of this drug evaluation started in Dec. 2007. It is a multicentered, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety trial in patients with mild to moderate Alzheimer’s disease who are apolipoprotein E4 non-carriers. The study is expected to be completed in Dec. 2010
For those who would like to enroll in the study, we present the following material:
Diagnosis of probable AD
Age from 50 to less than 89
Mini-Mental Status Exam score of 16-26 inclusive
Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
Stable doses of medications (cholinesterase inhibitors and memantine allowed)
Caregiver able to attend all clinic visits with patient
Significant neurological disease other than AD.
Major psychiatric disorder.
Significant systemic illness.
History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years.
Smoking greater than 20 cigarettes per day.
Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications.
Prior treatment experimental immunotherapeutics or vaccines for AD.
Women of childbearing potential.
Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574132
Telephone: 1 866 446 5463
(5/21/07)- The Alzheimer’s disease Cooperative study (ADCS) has received $52 million over 6 years to test drugs for their effectiveness in slowing down the progression or treating the symptoms of AD. The ADCS is a consortium of centers that will be conducting clinical trials, with the University of California, San Diego (UCSD) coordinating the work done at 70 centers in the United States and Canada. Richard J. Hodes, Director of National Institute on Aging (NIA), is quoted as saying: "We have learned a great deal from basic and observational research about how Alzheimer’s and other neurodegenerative diseases develop. The consortium’s work will translate this knowledge in clinical trials of interventions that target the mechanisms underlying AD."
The ADCS was established in 1991 bringing together leading researchers to carry out clinical trials for promising new therapies for AD. Investigators in the consortium have done studies on vitamin E, selegiline, estrogen, NSAIDs and donepezil. There are also ongoing studies of statins, high dose folate/B6/B12 supplements, and valproate to determine whether these compounds can either slow decline or help delay symptoms that emerge in AD patients. They will now do trials with docosahexaenoic acid (DHA), an omega-3 fatty acid, intravenous immunoglobulin (IVIg), lithium and also study alternative ways for the very elderly to take part in research studies.
The principal investigator at UCSD is Leon Thal, MD, chair of the Department of Neuroscience. For more information about thesestudies check www.nia.nih.gov/Alzheimers/Researchinformation/ClinicalTrials
(11/6/06)- The following is a chart from the researchers at clinicaltrials.gov that are recruiting patients for AD research:
Therapy/What is it
Currently Used For
Patients being studied
The treatment and prevenention of osteoporosis in postmenopausal women
Women with AD
NIH, Indiana University, Kaiser Permanente and Stanford University
Has antioxidant properties: being studied for memory benefits etc.
Those with mild AD
National Center for Complementary and Alternative Medicines
Cholinesteraw inhibitors increase a brain chemical called acetylcholine; the supplement is being studied for memory benefits
Over 55 with AD
The National Institute on Aging
Atorvastatin (Lipitor) plus a cholinesterase inhibitor
Those with mild to moderate AD, from 50-90 years old
General all around good health
Those with mild cognitive impairment
Seattle Institute for Biomedical and Clinical Research; Alzheimer's Association
Source: The researchers: clinicaltrial.gov
(8/04/06)- Insulin Sensitizer Rosiglitazone (Avandia) and APOE4 in Alzheimer’s Disease
According to the Clinical Trials.gov site (viewed Aug. 1, 2006), GlaxoSmithKline is set to launch a study of Rosiglitazone (Extended Release Tablets) as adjunctive therapy for subjects with mild to moderate Alzheimer’s disease (Clinical Trials. Gov Identifier NCT00348309). The study will be a randomized, double-blind, placebo control, parallel assignment efficacy study to investigate the efficacy of rosiglitazone (Rosiglitazone is sold under the brand name Avandia) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. They expect to enroll 1392 subjects at a number of sites throughout the USA.
In the publication CNS Drugs 2003,17(1):27-45, G. S. Watson and S. Craft (Geriatric Research, Education and Clinical Center, Veterans Affairs Puget Sound Health Care System, Seattle WA) reviewed evidence suggesting that insulin resistance plays a role in the pathophysiology and clinical symptoms of Alzheimer disease. Based on this evidence, these researchers proposed that the treatment of insulin resistance may reduce the risk or retard the development of Alzheimer’s disease. This has lead to investigators looking at the role of insulin sensitizers as a treatment. Insulin resistance refers to clinical condition in which the biologic response to insulin is diminished to below normal levels.
"University of Buffalo endocrinologists, led by Paresh Dandona, M.D., professor of medicine and head of the Division of Endocrinology in the UB School of Medicine and Biomedical Sciences, have been studying the anti-inflammatory properties of insulin and insulin sensitizers and their potential use in treatment and prevention of atherosclerosis, one of the leading causes of heart attacks.
Atherosclerosis, or hardening of the arteries, begins as an inflammation of the blood-vessel wall. Persons with diabetes are at increased risk of developing atherosclerosis and heart disease. Dandona’s lab has shown in research with a small group of obese non-diabetic volunteers that rosiglitazone decreased the levels of oxygen free radicals, which can begin the inflammation cascade by injuring blood-vessel linings. The drug also decreased the levels of several blood markers of inflammation." (Information accessed Aug. 2, 2006 at www.innovations-report.de/html/berichte/medizin_gesunheit/bericht-10622.htm)
Alzheimer’s disease patients treated with rosiglitazone maleate, an insulin sensitizer and mitochondrial stimulator appear to have improved cognition. (See: M.E. Risner et al, "Efficacy of rosiglitazone in a genetically defined population with mild to moderate Alzheimer’s disease, Pharmacogenomics J. (in press) 2006 and S. Ye et al., "Apolipoprotein (apo) E4 enhances amyloid ß peptide production in cultured neuronal cells: APOE structure as a potential therapeutic target." Proc Natl Acad Sci 2005; 102:18700-5.)
The scientific community is hard at work looking at the properties and function of APOE. They now know that APOE plays a basic role in the transport of lipids in the body as well as in the repair of neurons. Human APOE is 299 amino acids long and its gene is found on chromosome 19. The three variants of APOE are called alleles-ApoE2, ApoE3, ApoE4. The latter allele is considered a major risk factor for Alzheimer’s disease. Robert Mahley and Xadong Huang writing in The Scientist, 2006; 20(4):49-54 believe "that apoE4 works in concert with a variety of insults or so-called second hits to lead to neuropathology".
These three alleles differ only at two positions, 112 and 158. The differences result in different biophysical properties that likely contribute to the finding that ApoE4 imposes malfunctioning cell machinery leading to pathology. It appears to "enhance amyloid beta production, potentiate amyloid beta-induced lysomal leakage and apoptosis, and enhance neuron-specific proteolysis (the directed degradation (digestion) of proteins by cellular enzymes called proteases or by intramolecular digestion, ed. insert) resulting in translocation of neurotoxic apoE4 fragments into the cytosol (the internal fluid of the cell, and a portion of cell metabolism occurs here, ed. insert) where they are associated with cytoskeletal disruption and mitochondrial dysfunction". (The Scientist. ibid) The goal of those researchers looking at a drug therapy for Alzheimer’s disease is to convert the apoE4 to apoE3-like molecule. If this could be done, the apoE3 allele is not neuropathologically detrimental, thus reducing the risk of developing Alzheimer’s disease. The question remains whether rosiglitazone is a promise of a cure for one of our most debilitating ills. Meanwhile, research continues on many different fronts to deal with Alzheimer’s disease, that, as the elderly population increases, is looming as a large health crisis in the near future.
(11/)The information below was taken from the Nov. 9, 2004 issue of Neurology. It provides centers where interested individuals may get involved in research studies. There is no guarantee that you will be involved in the reseach arm of the study.
(6/25/04)- The Alzheimer's Disease Education & Referral Center (ADEAR) seeks 400 volunteers to test whether high-dose supplements of B6, B12 and folate will slow the progression of Alzheimer's Disease. Please contact the Alzheimer's Disease Education & Referral Center (ADEAR) at (800) 438-4380 orwww.alzheimers.org
The Alzheimer's Disease Education and Referral Center (ADEAR) is looking for volunteers to test whether a natural cholinesterase inhibitor with additional antioxidant and neuroprotective properties (Huperzine A) will slow the progression of Alzheimer's Disease. Please contact the Alzheimer's Disease Education & Referral Center (ADEAR) at (800) 438-4380 orwww.alzheimers.org
The Alzheimer's Disease Education & Referral Center (ADEAR) Previous research has shown that Valproate, an anticonvulsant drug, may be helpful in slowing AD and some of its symptoms. For information about the VALID study and location of research sites, please call: The Alzheimer's Disease Education & Referral Center (ADEAR) (A Service of the National Institute on Aging) at (800) 438-4380 orwww.alzheimers.org
The Alzheimer's Disease Education & Referral Center (ADEAR) - Can Cholesterol-lowering drugs help slow Alzheimer's Disease? Some evidence suggests that statins may also be able to slow the devastating effects of Alzheimer's disease (AD) on the brain. For information about participation in the CLASP research study and location of research sites, please call: The Alzheimer's Disease Education & Referral Center (ADEAR) (A Service of the National Institute on Aging) at (800) 438-4380 (toll-free).
Antigonadotropin - Leuprolide in Alzheimer's Disease Drug Investigation (ALADDIN) - is a clinical trial investigating the safety and effectiveness of leuprolide (a hormone drug) to improve the cognitive function and slow the progression of Alzheimer's Disease (AD). The study seeks men 65 years and older with mild to moderate Alzheimer's disease. Visithttp://www.clinicaltrials.gov then enter ALADDIN in the search request box to view locations of recruiting sites or to learn more about the study.
The Experimental Therapeutics Branch, NINDS, is recruiting patients (age 55-85) with mild-moderate Alzheimer's disease for an experimental study involving the investigational new drug CX516. The outpatient study duration is about 3 months. There is no cost to participants, including travel to NIH. Contact Mae Brooks, at (301) 496-4604 email@example.com. This study is carried out in compliance with testing and safety standards of U.S. Department of Health and Human Services.
Margolin Brain Institute - If you are at least 45 years old with mild memory loss, you may qualify to participate in a clinical research trial of an investigational medication. All study related evaluations and study medication are provided at no cost and there is a travel allowance. Contact the Margolin Brain Institute. Contact the Margolin Brain Institute (559) 299-1515.
If you have memory loss as a result of a stroke, you may be eligible to participate in a medical research study. Participants will receive study related evaluations and medications at no cost, which may include: CT or MRI Scan, ECG, Lab Tests, Memory Testing, Physical Exam, or Study Medication. For more information, Contact the Margolin Brain Institute (559) 299-1515.
Patients with mild-to-moderate Alzheimer's disease may qualify to receive an investigational Alzheimer's medication. Patients may continue taking prescription Alzheimer's medication. Qualified applicants receive travel reimbursement. Contact the Margolin Brain Institute (559) 299-1515.
Patients with mild-to-moderate dementia may qualify to participate in a clinical research study of an investigational medication. Study medications and all "assessments are provided at no cost, and up to $520.00 in travel reimbursement. Contact the Margolin Brain Institute (559) 299-1515.
Patients with moderate to severe Alzheimer's disease may qualify to participate in a research study of an investigational drug. Study related evaluations and study drug are provided at no cost. There will be $25.00 per completed visit provided for travel reimbursement Contact the Margolin Brain Institute (559) 299-1515.
National Institute of Aging will be treating people with Alzheimer's Disease who suffer from hallucinations, delusions, agitation, or aggression with risperidone, an FDA-approved antipsychotic medication. Each participant must have a family member or caregiver who can assist with adherence to treatment and provide information during the research study. There are sites in New York, NY; Tuscaloosa, AL; Iowa City, IA; and Charleston, SC. Please contact program manager at (212) 543-6132
UCLA Kagan Alzheimer's Disease Research Center - Curcumin study. The curcumin study is a 12 month, phase II, UCLA initiated drug trial, with the first 6 months being randomized, placebo controlled, and the second 6 months being open label. This study will be investigating the safety and effectiveness of curcumin, a natural dietary component, with the antioxidant, anti-inflammatory and cholesterol lowering properties, to slow the progression on Alzheimer's disease. For more information, call (310) 206-3779.
As the population ages, it has been predicted that more individuals will develop Alzheimer’s disease. Alzheimer's disease ranks as the eighth-leading cause of death in the U.S., and accounted for 44,507 deaths in 1999. It is estimated that Alzheimer’s disease costs society about $33 billion annually, with average lifetime cost per individual at about $174,000.
In 1999, the United States government will spend approximately $400 million for research, which works out to $1 for every $250 the disease now costs. This money mainly goes for clinical trials designed to find new and better medications to deal with the symptoms related to the disease, and hopefully to cure the disease.
There may be some readers of this article who know of individuals who would like to participate in this research with the knowledge that in a research project the investigators are looking at the product rather than the individual patient. These trials are funded by the National Institute of Health and are public information.
We will send a list of the study sites, with names of the Principle Investigators to those readers who request it in writing (Rehabilitation Strategies Unlimited, c/o Harold Rubin, 255 West 90th Street, New York, NY 10024). Please include a self-addressed stamped envelope. We will also include names of pharmaceutical companies that sponsor indigent drug services for needy individuals who would otherwise be unable to afford such medication.
The following trials are now available in the Alzheimer's Disease Education and Referral Center's Clinical Trials Database
(http://www.alzheimers.org/trials/index.html), a service of the National Institute on Aging.
NEW---Valproate in Dementia (VALID)---VALID is a 26-month research study conducted at 30 sites nationwide to test whether valproate (an anti-seizure drug) is effective in delaying, weakening, or possibly even preventing difficult behaviors (agitation, psychosis) in people with early to middle stage AD, and whether it has any effect on slowing the progression of AD itself.
Researchers for this study are looking for participants who:
-are age 55-90 (inclusive),
-have been diagnosed with probable Alzheimer's disease (AD), and
-have not experienced agitation or psychosis since the onset of AD.
The VALID study is sponsored by the Alzheimer's Disease Cooperative
Study based at the University of California, San Diego and funded by the U.S. Government's National Institute on Aging, one of the National
Institutes of Health.
For more information, including specific eligibility criteria, see the full record at:http://www.alzheimers.org/dbtw-wpd/exec/dbtwpcgi.exe
UPDATED---Antigonadotropin-Leuprolide in Alzheimer's Disease Drug Investigation (ALADDIN)-VP 104---
The ALADDIN study, a research study to investigate the safety and effectiveness of leuprolide (a hormone drug) to improve cognitive
function and slow the progression of AD, is now seeking men age 65 years and older with mild to moderate Alzheimer’s disease who reside in the
community. This Phase II study is sponsored by Voyager Pharmaceuticals.
For more information, including specific eligibility criteria, see the full record at: http://www.alzheimers.org/dbtw-wpd/exec/dbtwpcgi.exe
* NEW! Cholesterol Lowering Agent to Slow Progression of AD (CLASP) -sponsored by the Alzheimer's Disease Cooperative Study and funded
by the National Institute on Aging. This study, at 40 sites in the U.S., seeks participants with mild to moderate AD to test the effectiveness of the cholesterol-lowering statin drug simvastatin in slowing AD.
* Updated! Treatment of Agitation/Psychosis in Dementia and Parkinsonism (TAP/DAP) - This study seeks patients with a primary dementia (probable Alzheimer's disease or dementia with Lewy bodies, also now includes Parkinson's disease with dementia) complicated by coexistent parkinsonism to test the efficacy and tolerability of quetiapine and donepezil, used alone or in combination, to treat psychosis and/or agitation.
The full records for both new trials are attached below.
You can also view the records on our web site at http://www.alzheimers.org/trials/basicsearch.html -
click on "View All Trials" and select the trial you would
like to view. For questions, call us toll-free
at 1-800-438-4380 (Monday-Friday, 8:30am-5pm Eastern Time).
The following is a copy of an e-mail that Harold Rubin received from:
Outreach and Promotion Specialist
Alzheimer's Disease Education and Referral Center
Dear Mr. Rubin -
Thanks so much for your inquiry about Alzheimer's disease clinical trials. I had a chance to look at your Web site which is terrific!
Since we talked, the Healthy Aging and Memory Study has completed recruitment and is no longer seeking volunteers.
The Homocysteine study is not yet underway - the study sites are in process of gaining approval from their Institutional Review Boards (IRBs). The name of the study is "VITAL" (VITamins to slow ALzheimer's) and it will seek to discover whether lowering homocysteine with
high-dose supplements of folate, B6, and B12 will slow cognitive decline in people with AD. Paul Aisen, MD, of Georgetown University is directing the study. Approximately 40 sites will enroll a total of 400 volunteers age 55 or older with mild to moderate AD for this 18-month trial.
You are signed up for our e-mail alert service and will receive an e-mail when any new trials are recruiting participants. You can also check back on our Web site at www.alzheimers.org.
Thanks again for your interest and for spreading the word! Please let me know if I can be of any further assistance.
Outreach and Promotion Specialist
Alzheimer's Disease Education and Referral Center
The following is a list of Web sites that may help you gather more information about studies that are presently being conducted to further the research on Alzheimer's disease.
The ClinicalTrials.gov web site developed by National Institute of Health through its National Library of Medicine, contains about 5,000 clinical studies sponsored primarily by the National Institutes of Health.
The Alzheimer's Disease Clinical Trials Database, a joint project of the FDA and National Institute on Aging, provides directories of clinical trials by state, with detailed information on the experimental drug, criteria for inclusion and exclusion, and contact information.
The CenterWatch Clinical Trials Listing Service web site is less detailed, but includes trials not listed in the Alzheimer's Disease Clinical Trials Database.
The Alzheimer's Association can provide a list of study centers in your region. Send e-mail or phone 800-272-3900.
There are presently at least three different clinical trials that are recruiting subjects in connection with possible modes of prevention of Alzheimer's disease. ADAPT, PREPARE and PREADVISE mentioned in the chart below are sponsored by the National Institute on Aging. The National Center for Complimentary and Alternative Medicine is sponsoring the GEM study at the National Institute of Health.
ADAPT (AD anti-inflammatory Prevention Trial)
People 70+ who have not been diagnosed with AD but have a relative who had the disease
PREPARE ( Preventing Postmenopausal Memory Loss and AD with Replacement Estrogens)
1 877 DELAY-AD
PREADVISE (Prevention of AD by Vitamin E and Selenium)
Men 60 to 90 years of age
GEM ( Ginkgo Evaluation of Memory)
People 75+ with dementia
Closed to new participants
The Danish pharmaceutical company Lundbeck LUN.CP said its drug Memantine for treatment of Alzheimer's disease was recommended for approval by a European Union committee. Forest Labs has the marketing rights in the U.S. Memantine is the first drug to do clinical trials in patients with severe Alzheimer's although it is not likely to be more effective than the current Alzheimer drugs on the market. The drug is not expected to be on the U.S. market for approximately two years.
Elan and Wyeth-Ayerst Labs (a division of American Home Products) announced that it has suspended patient dosing in it Phase 2A study of AN-1792, which we discuss in Study Number 2 below. The study has been suspended and the drug will not be going forward in development because four patients were reported to have signs of inflammation of the Central Nervous System (CNS).
The December 21, 2001 issue of Nature indicated that researchers using a transgenic mouse model of Alzheimer's disease were able to demonstrate that accumulation of amyloid-beta protein deposits correlated with cognitive decline. They showed that a vaccine could reduce the amyloid-beta protein deposits and reduce impairments in learning and memory. This sounds like good news, but for many in the scientific community, there still is a question of whether it is the amyloid-beta plaques that cause dementia. Some researchers are focusing in on two separate Alzheimer disease genes located on chromosome 10 that play a part in regulating amyloid-beta levels.
A number of our readers have asked us about volunteering for studies being done with possible new AD medications. We recently received the following e-mails outlining two current studies that are recruiting subjects. There are phone numbers listed where you could check it out for yourself, since we make no recommendations in connection with the studies.
****To Subscribe or Unsubscribe to any of the ADEAR e-mail alert lists please go to [www.alzheimers.org/maillist.html].*****
To avoid unauthorized addition or deletion of another person's e-mail address, we cannot honor e-mail subscribe/unsubscribe requests - please go to www.alzheimers.org/maillist.html to subscribe or unsubscribe.
This trial record can be viewed by clicking on the link at [http://www.alzheimers.org/trials/newtrials.html].
Study number 4
BRIEF TITLE-Healthy Aging and Memory Study
OFFICIAL TITLE-Alzheimer's Disease Prevention Instrument Protocol
SPONORING AGENCY: National Institute on Aging
DRUG(S) (GENERIC NAME [BRAND NAME]):
1. 75 years or older.
2. Fluent in English or Spanish.
3. Stable medical condition for four weeks prior to screening visit.
4. Stable medications for four weeks prior to screening visit.
5. Either cognitively normal, or mild cognitive impairment (MCI). If MCI, the subject's CDR at screening must have a global score of 0.5.
6. mMMSE score greater than 88 for subjects with greater than 8 years of education, or greater than 80 for subjects with less than 8 years education, and Free and Cued Selective Reminding Task total free plus cued recall score greater than 44 with three learning trials.
7. Willing to participate in four to five year follow-up study.
8. Willing to identify person who can serve as study partner, as well as attend all clinic visits with study participant. The study partner should be someone who has contact with the study participant at least twice a week in person or by phone.
9. Study subjects and their study partners must be able to read and complete study forms.
INCLUSION SEX: Both
1. Meets DSM IV criteria for dementia.
2. History of clinically significant medical illness that would interfere with participation in trial, including active malignancy, myocardial infarction, or cerebrovascular accident within the past year.
3. Alcohol or substance abuse and/or active major psychiatric disorders.
4. Concurrent participation in a clinical drug trial.
5. History of mental retardation.
1. Antipsychotic agents. These agents are allowed if low doses are prescribed for reasons other than treatment of psychiatric symptoms, and the doses are stable for at least four weeks prior to screening.
2. Antiparkinson drugs.
3. Medications for treatment of dementia.
4. Antidepressant therapy is acceptable as long as the dosage has been stable for four weeks prior to screening.
5. Vitamin E in excess of 430 IU per day.
CONDITION(S) STUDIED-Alzheimer's disease
DESCRIPTION FOR HEALTH PROFESSIONALS
This project will focus on the development and testing of efficient, cost effective measures that are specifically designed for use in Alzheimer's disease primary prevention trials. The new or improved measures that have been developed will be evaluated in 650 nondemented subjects enrolled in a simulated Alzheimer's disease primary prevention trial. Once enrolled, subjects will be followed for four years with annual clinical evaluations and interim six-month phone calls.
DESCRIPTION FOR THE PUBLIC
This project will focus on the development and testing of efficient, cost-effective tests and measures that are specifically designed for use in Alzheimer's disease primary prevention trials.
Birmingham, AL 35294-1150: University of Alabama, Birmingham: Jo Ann Parrish, LPN: Tel: 205-934-6223: firstname.lastname@example.org
Sun City, AZ 85351: Sun Health Research Institute: Suhair Stipho, MB, CH B: Tel: 623-875-6516: email@example.com
Sacramento, CA: University of California, Davis: Bobbi Henk, RN, MSN: Tel: 916-734-6750: firstname.lastname@example.org
Palo Alto, CA 94304: Stanford/VA Aging Clinical Research Center: Heather Fiedler-Greene, MA: Tel: 650-852-3234: email@example.com
Irvine, CA 92697-4285: University of California, Irvine: Catherine McAdams-Ortiz, RN, MSN: Tel: 949-824-8726: firstname.lastname@example.org
Los Angeles, CA 90095-1769: University of California, Los Angeles: Susan O'Connor, RNC: Not Yet Recruiting: -
LaJolla, CA 92037: University of California, San Diego: Mary Pay, RN, CNP: Tel: 858-622-5800 Fax: 858-622-1017: email@example.com
Los Angeles, CA 90033-1039: University of Southern California: Nansi A. Taggart, RN, BSN, MA: Not Yet Recruiting: -
New Haven, CT 06510: Yale University School of Medicine: Shannon Savarese: Tel: 203-764-8100: firstname.lastname@example.org
Washington, DC 20007: Georgetown University: Carolyn Ward, MSPH: Tel: 202-784-6671 Fax: 202-784-4332: email@example.com
Boca Raton, FL: Baumel-Eisner Neuromedical Institute: Fannie Levinson: Tel: 800-755-1999: firstname.lastname@example.org
Fort Lauderdale, FL 33321: Baumel-Eisner Neuromedical Institute: Fannie Levinson: Tel: 800-755-1999: email@example.com
Miami Beach, FL 33154: Baumel-Eisner Neuromedical Institute: Fannie Levinson: Tel: 800-755-1999: firstname.lastname@example.org
Tampa, FL: University of South Florida: Dolina Bois, MA: Tel: 813-974-4355: email@example.com
Jacksonville, FL: Mayo Clinic, Jacksonville: Francine Parfitt, MSH, CCRC: Not Yet Recruiting: -
Miami Beach, Fl 33140: Wien Center (Miami Beach): Peggy D. Roberts: Tel: 305-674-2424: firstname.lastname@example.org
Atlanta, GA: Emory University: Lisa Kilpatrick, BS, MS: Tel: 404-728-6590: email@example.com
Chicago, Il: Northwestern University: Laura Herzog, MA: Tel: 312-695-2343: firstname.lastname@example.org
Chicago, Il: Rush Alzheimer's Disease Center: Rose Marie Ferraro, LVN, AS: Tel: 312-942-8264: email@example.com
Indianapolis, IN 46202: Indiana University Alzheimer's Center: Nicki Coleman RN: Tel: 317-274-1351: firstname.lastname@example.org
Lexington, KY: University of Kentucky: Kelly Woodall, RN: Tel: 859-257-5562: email@example.com
Balitimore, MD: Johns Hopkins University: Cynthia Munro, PhD: Tel: 410-614-7785: firstname.lastname@example.org
Boston, MA 02115: Brigham and Women's Hospital: Kara Campobasso, MA, PA: Tel: 617-732-7992: email@example.com
Boston, MA: Boston University School of Medicine: Jeri Jewett: Tel: 617-638-5430: firstname.lastname@example.org
Ann Arbor, MI: Michigan Alzheimer's Disease Research Center: Linda V. Nyquist, PhD: Tel: 734-936-6078: email@example.com
Rochester, MN: Mayo Alzheimer's Disease Center: Joan McCormick, BSN, RN: Tel: 507-284-7906: firstname.lastname@example.org
St Louis, MO: Washington University: Pamela Millsap, BSN: Tel: 314-286-2363: email@example.com
Las Vegas, NV: University of Nevada, Las Vegas: Marie L, Stallbaum, BSN: Tel: 702-671-5021: firstname.lastname@example.org
New York, NY: Columbia University: Ruth Tejeda, MD: Tel: 212-305-5805: email@example.com
New York, NY: Mt. Sinai Medical Center: Adriana DiMatteo, MA: Tel: 212-241-0438: firstname.lastname@example.org
New York, NY: New York University School of Medicine: Maria Vlassopoulos: Tel: 212-263-5708: maria.vlassopoulos@.med.nyu.edu
Rochester, NY: University of Rochester: Colleen McCallum, MSW: Tel: 716-760-6574: email@example.com
Cleveland, OH: University Hospitals of Cleveland: Nancy A. Slocum, RN, MPH: Tel: 216-844-6328: firstname.lastname@example.org
Portland, OR: Oregon Health Sciences University: Georgene Siemsen, MS, RN: Not Yet Recruiting: -
Philadelphia, PA: University of Pennsylvania: Kris Gravanda, BA: Tel: 215-349-5903: email@example.com
Pittsburgh, PA: University of Pittsburgh: Patrick Ketchel, MEd: Tel: 412-692-2721: firstname.lastname@example.org
Pawtucket, RI: Memorial Hospital of Rhode Island: Meg Lannon, RN, MS: Tel: 401-729-3750: email@example.com
North Charleston, SC 29406: Medical University of South Carolina: Effie Hatchett, RNC: Tel: 843-740-1592: firstname.lastname@example.org
Dallas, TX: University of Texas Southwestern Medical Center: Robbin Peck, AD: Tel: 214-648-7457: email@example.com
Study No. 3
BRIEF TITLE :PREADVISE
OFFICIAL TITLE Prevention of Alzheimer's Disease by Vitamin E and Selenium
SPONORING AGENCY: National Institute on Aging National Cancer Institute
Dr William Markesbery
Dr Frederick Schmitt
Dr Richard Kryscio Sanders-Brown Center on
DRUG(S) (GENERIC NAME [BRAND NAME]): Vitamin E, ,Selenium
PHASE Phase III
1. Participating in SELECT prevention study.
2. 62 years or older, or 60 years or older if African-American or Hispanic.
3. General good health with no neurological or psychiatric illness.
1. Neurologic illness such as Parkinson's disease, Alzheimer's disease, seizures, stroke, or multiple sclerosis.
2. Serious medical illness such as cancer, or liver, blood, lung, gallbladder, or kidney disease.
3. Psychiatric illness such as untreated depression, anxiety, schizophrenia, or alcohol or substance abuse.
4. Taking prescription medications that can affect memory and thinking.
Participants accepted into the study will be given vitamin E and selenium supplements alone or in combination, or a placebo. All participants receive a multivitamin. They will visit the study site every six months for seven to twelve years. If participating in the PREADVISE study, in addition to the SELECT study, a short memory test will also be administered on an annual basis to detect cognitive changes.
DESCRIPTION FOR THE PUBLIC
The Prevention of Alzheimer's Disease with Vitamin E and Selenium (PREADVISE) trial is an important addition to the Selenium and Vitamin E Cancer Prevention Trial SELECT). As a prevention trial, PREADVISE is trying to find out if taking selenium and/or vitamin E supplements can help to prevent memory loss and dementia such as Alzheimer's disease.
For trial sites for the SELECT and PREADVISE trials, please visit http://www.swog.org and read the information on the SELECT study.
Study Number 1
PROTOCOL NUMBER : IA0031
BRIEF TITLE: Effect of the HMG-CoA Reductase Inhibitor Atorvastatin Calcium, Lipitor, in the Treatment of Alzheimer's Disease
DESCRIPTION FOR THE PUBLIC
Assessment of the clinical benefit of a cholesterol- lowering drug in the treatment of Alzheimer's disease.
Institute for the Study of Aging
David Lawrence Sparks, PhD Sun HealthResearch Institute
David Lawrence Sparks, PhD 623-876-5463
Larry.Sparks@SunHealth.org 10515 West Santa Fe Drive, Sun City AZ 85351
DRUG(S) (GENERIC NAME [BRAND NAME]):
MANUFACTURER(S): Pfizer, Inc.
PHASE Phase II
1. Signed consent form prior to participation.
2. Diagnosis of probable or possible Alzheimer's disease according to NINDS-ADRDA and DSM- IV criteria for dementia.
3. Not actively participating in another clinical drug trial.
4. MMSE range 12-28 at entry.
5. Hachinski Modified Ischemic score <= 4.
6. Accompanied by appropriate caregiver who can aid in administration of medication and make assessments.
7. Good general health as evidenced by physical, neurological and clinical laboratory examination.
8. Education level >= 9th grade or equivalent.
9. Fluent in the English language.
10. Able to understand and give informed consent.
11. Reliable caregiver.
12. Able to complete neuropsychological tests.
14. On stable doses of medications for the treatment of non-excluded medical conditions for four weeks prior to screening.
15. Able to participate in all scheduled evaluations.
16. Geriatric Depression Scale <= 20.
17. Not exceeding 400 IU of Vitamin E for 30 days.
18. For patients currently taking donepezil, they must remain on stable dose for at least three months. Individuals taking stable doses of other cholinesterase inhibitors for at least three months can be included, but no study subject may initiate use of any cholinesterase inhibitor after entrance to trial.
19. Individuals of both sexes over 50 years of age will be eligible.
INCLUSION SEX: Both
1. Significant neurological or psychiatric disease other than Alzheimer's disease.
2. Patients with known or suspected Parkinson's disease or Dementia with Lewy Bodies according to McKeith criteria.
3. Significant systematic illness (including uncontrolled hypertension) or organ failure.
4. History of myocardial infarction within one year or history of significant untreated cardiac or thromboembolic vascular disease.
5. Current chronic use of anti-cholinergic medications including anti-histamines, Artan or Cogentin. Stable doses of anxiolytics, sedatives, hypnotics, antipsychotics, and SSRI antidepressants are acceptable. The use of antipsychotics or tricyclic antidepressants must be reviewed prior to entry.
6. Diagnosis of major depression in the prior two years according to DSM-IV criteria.
7. Allergies to atorvastatin or HMG-CoA reductase inhibitors.
8. Pregnant females.
9. History of head injury.
10. Use of a cholesterol lowering drug at time of entry.
11. History of significant liver disease and/or elevated transaminases.
12. Cholesterol level lower than 90 mg at initial screening.
1. Vitamin E in excess of 400 IU per day, washout to that level.
2. Any medication contraindicated by the package insert.
3. Subjects may continue stable dose of cholinesterase inhibitors.
CONDITION(S) STUDIED: Alzheimer's disease
DESCRIPTION FOR HEALTH PROFESSIONALS
Assessment of the clinical benefit of a cholesterol- lowering drug in the treatment of Alzheimer's disease.
General use or self administration of grapefruit products may prolong the effects of active study medication by reducing metabolism.
Sun Health Research Institute, Cleo Roberts Center for Clinical Research, Sun City AZ, Contact:D. Larry Sparks, Tel:623-876-5463, E-Mail:Larry.Sparks@SunHealth.org
Study Number 2-This study has been suspended and will not be going forward.
PROTOCOL NUMBER :IA0030
BRIEF TITLE: Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
DESCRIPTION FOR THE PUBLIC
The study enrolled approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe. Patients received either AN-1792 or placebo, and were evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology. The goal of the study was to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease. As we discussed above this study has been stopped because of problems that have developed in some of the patients who received the drug.
SPONSORING AGENCY: Elan Pharmaceuticals, Wyeth-Ayerst
CONTACT PERSON: Elan Pharmaceuticals 888-635-9987 (US), 800-898-3736 (International)
Data was presented at the World Congress of Neurology, based on a 12-month study of Reminyl (R) (galantamine hydrobromide) that the drug which has been approved for treatment of mild to moderate Alzheimer's disease, also may be effective in treating dementia in individuals with cerebrovascular disease. Reminyl is comarketed by Shire Pharamaceutical and Johnson & Johnson. Janssen Pharmaceutical Products announced that the FDA has approved a new oral solution formulation of its Alzheimer's disease therapy Reminyl. It may prove valuable to those patients who have difficulty swallowing pills.
The FDA has granted approval to Johnson & Johnson for its drug Reminyl to treat mild-to-moderate cases of Alzheimer's disease. According to a company spokesman the drug will be available to the public starting in May 2001. Its price will be about the same as 2 other medications now being used to treat Alzheimer's disease. The other 2 drugs are Aricept, sold by Pfizer, Inc., and Exelon sold by Novartis AG of Switzerland. Reminyl was shown to be effective in improving or helping to stabilize patients' ability to think and perform daily tasks of living. The test group used to evaluate the drug consisted of 2,650 subjects. Side effects reported in connection with taking the drug included nausea, vomiting, anorexia, diarrhea and weight loss. The Janssen Research Foundation, a subsidiary of Johnson & Johnson developed the drug, under a co-development and licensing agreement with Shire Pharmaceuticals Group PLC.
The May 10, 2000 issue of JAMA (an American Medical Association publication) column titled "The World in Medicine" discussed a "promising" new drug for Alzheimer’s disease treatment. The drug, Galantamine Hydrobromide, marketed as Reminyl, is for treatment of mild to moderate cases of Alzheimer’s disease. The European studies indicated that 24 mg/d is the dosage that is most effective, improving scores on the Alzheimer’s Disease Assessment Scale in memory, language, orientation and other aspects of cognition over a one year period.
Galantamine is classified as Acetylcholinesterase inhibitors. It also appears to act on nicotine receptors in the brain. Both the acetylcholine and nicotine receptors have been suggested as areas related to cognitive impairment.
It remains to be seen whether this drug is any better than those already on the market in the USA. It does not pretend to be a cure for Alzheimer’s disease, but may retard the cognitive decline.
Researchers are still trying to pin down the process of memory impairment in the brain. Neurotransmission in the brain is a complex phenomenon, involving different receptor sites. Different mechanisms of action may precipitate different profiles of AD and call for different forms of treatment. The hallmarks of Alzheimer’s disease involve extensive amyloid plaque formation, neuritic dystrophy, synaptic loss and gliosis. These pathological and biochemical changes are the target of drug treatment. It is not yet known what causes these pathologic changes, although genetics and age are risk factors and theories abound.
Media reports have been suggesting that a "vaccine" is on the way which is being developed by Elan Corporation. Please note that research is only in the first clinical trial phase of development to make people immune to beta-amyloid plaque formation. This month's issue of the journal Nature reports on a study performed by scientists at Massachusetts General Hospital in Boston and Elan Corp of Dublin. The brains of mice with genetically induced Alzheimer's disease were injected with an antibody known to attack beta-amyloid, a plaque that normally builds up and clogs the brains of people with Alzheimer's disease. A protein injection melted away the brain-clogging beta-amyloid plaque. The literature indicates that you can have beta-amyloid plaque formation and not have symptoms of AD and that plaque formation is a ubiquitous phenomenon in human beings. It will be many years before this vaccine becomes available to the public and then, only if it passes all phases of drug development and long-term clinical use. Some scientists believe that the beta-amyloid buildup is merely a symptom of Alzheimer's disease and that therapies aimed at clearing them up will not cure the underlying disease.
To keep our readers informed, we present a further list of drugs in clinical trails. These drugs are based on the theory that stimulating the cholinergic, muscurinic or nicotinic synapses could alter the progression of the disease. Most are aimed at palliative treatment. Presently, cholinesterase inhibitors are the only approved pharmaceutical treatment of AD. Cholinesterase inhibitors block acetylcholinesterase, preserving acetylcholine for a longer period of time, thus preserving brain cell communication. The most common adverse events of this class of drugs involve the gastrointestinal tract: nausea, vomiting and diarrhea. Physicians will lower the dose when these affects show up, until the individual becomes tolerant and then building the dose up again. The drugs listed below may have a wider range of adverse effects and are not available for treatment of AD in the USA.
See: Alzheimer's Disease Part I-Medications for Alzheimer's.
See: Alzheimer’s Disease Part II- Selegiline and AD.
See: Alzheimer's Disease Part III- Use of Gingko Biloba in memory problems of Alzheimer patients
See: Part IV-Alternative Treatments for AD
See: Part V-Possible New Drugs for Alzheimer's Disease
See: Part VI-Early Diagnosis
See: Part VII-Metrifonate
See:Alzheimer's Disease PartVIII - Implications of Longer Life Expectancies
See: Alzheimer's Part IX-Ethical Care Principles
See: Alzheimer's Disease-Part X-Estrogen and Alzheimer's Disease
See: Alzheimer's Disease Part XI-Pocket Smell Test (PST)
See: Alzheimer's Disease Part XII-MAO-B
See: Alzheimer's Disease Part XIII -Critical Flicker Fusion Threshold Test
See: Alzheimer's Disease Part XIV-Donepezil
See: Alzheimer's Disease Part XV-Cerebrolysin
See: Alzheimer's Disease Part XVI-MCI
See: Alzheimer's Disease Part XVII-Summary
See: Alzheimer's Disease Part XVIII-NO Releasing NSAIDs
See: Alzheimer's Disease Part XIX-Vitamin E
See: Alzheimer's Disease Part XXI-The Brain
See Dementia with Lewy Bodies- Part XXII-by Gourete Broderick
See: Alzheimer's Disease-Part XXIII-HMG
See: Alzheimer's Disease-Part XXIV-A Prequel
See: Alzheimer's Disease-Part XXV-Psychosis
See: Alzheimer's Disease-Part XXVI-Amyloid-beta Hypothesis Controversy
See: Alzheimer's Disease-Part XXVII- AD and Diabetes
See: Alzhemeir's Disease-Part XXVIII - Insulin and AD
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Harold Rubin, MS, ABD, CRC, Guest Lecturer
Updated April 12, 2013
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