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Sponsors and Collaborators: |
University of California, Irvine Alzheimer's Association |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00580931 |
The purpose of this study is to determine whether nicotinamide, or vitamin B3, is safe and effective in the treatment of Alzheimer's disease.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Nicotinamide Drug: Enduramide placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Nicotinamide for the Treatment of Alzheimer's Disease |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Subjects will receive experimental drug in a blinded fashion.
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Drug: Nicotinamide
1500 mg twice a day for 6 months
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2: Placebo Comparator
Identical in size, shape and color to experimental drug.
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Drug: Enduramide placebo
1 tab twice a day
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The goal of this proposal is to show that, nicotinamide (NA), a B3 vitamin, is safe and effective for the treatment of patients with mild to moderate Alzheimer's disease (AD). NA is known to block the ability of certain proteins to regulate other proteins by removing their acetyl groups. Recent evidence has demonstrated that inhibitors such as NA prevent nerve cell degeneration in models of Huntington's disease (HD), Parkinson's disease and Lou Gehrig's disease (or ALS). Despite these beneficial effects in many different animal models, there have been no studies to date using these inhibitors in AD. In some of our recent studies we found that the potent inhibitor, NA, significantly improves learning and memory in transgenic mice that develop AD. NA treatment also resulted in striking changes in tau, a protein that abnormally accumulates in AD. NA has been extensively used in clinical studies over the last 40 years and is generally safe and well-tolerated. As NA is a safe and readily available vitamin supplement, our recent results provide a strong argument for a study of NA in patients with AD.
We therefore propose to treat 50 patients with mild to moderate AD with either NA (1500 milligrams twice a day) or an identical but inactive drug (placebo) for 24 weeks. At 6 week intervals we will assess functions such as learning and memory, and ability to carry out daily activities as well as caregiver reports using standardized tests. We will also perform spinal taps at the beginning and end of the study to measure the level of abnormal tau protein in the cerebrospinal fluid. Blood tests will periodically be done to assess liver function and complete blood counts. The results of this study may provide the basis for a more extensive study of NA for the treatment of mild to moderate AD.
Ages Eligible for Study: | 50 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ruth Mulnard, Ph.D. | (949) 824-7016 | ramulnar@uci.edu |
Contact: Steven S Schreiber, MD | 949-413-9016 | sschreib@uci.edu |
United States, California | |
UC Irvine School of Medicine | Recruiting |
Irvine, California, United States, 92697 | |
Contact: Steven S Schreiber, MD 949-413-9016 sschreib@uci.edu | |
Contact: Ruth Mulnard, Ph.D. 949-824-7016 ramulnar@uci.edu | |
Principal Investigator: Steven S Schreiber, MD |
Principal Investigator: | Steven S Schreiber, MD | Regents of the University of California |
Responsible Party: | UC Irvine School of Medicine ( Steven S. Schreiber ) |
Study ID Numbers: | IIRG-07-61197 |
Study First Received: | December 24, 2007 |
Last Updated: | February 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00580931 History of Changes |
Health Authority: | United States: Institutional Review Board |
nutraceutical, dementia, cognition, HDAC inhibitor |
Antimetabolites Vasodilator Agents Vitamin B Complex Niacinamide Antilipemic Agents Alzheimer Disease Central Nervous System Diseases Trace Elements Cardiovascular Agents Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Nicotinamide Nicotinic Acids Vitamin B3 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Vitamins Micronutrients Nicotinic Acid Dementia Niacin Delirium |
Antimetabolites Vasodilator Agents Vitamin B Complex Niacinamide Molecular Mechanisms of Pharmacological Action Growth Substances Antilipemic Agents Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Cardiovascular Agents |
Brain Diseases Neurodegenerative Diseases Pharmacologic Actions Nicotinic Acids Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Vitamins Therapeutic Uses Micronutrients Dementia Tauopathies Niacin |