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Sponsors and Collaborators: |
National Institute on Aging (NIA) Alzheimer's Disease Cooperative Study (ADCS) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00117403 |
The purpose of this study is to examine the safety and effectiveness of two anti-oxidant treatment regimens in patients with mild to moderate Alzheimer's disease. The anti-oxidant treatments include vitamin E + C + alpha-lipoic acid, and Coenzyme Q (CoQ).
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Vitamin E, Vitamin C, and Alpha-lipoic Acid Drug: Coenzyme Q Drug: Placebo capsules Drug: Placebo wafers |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease |
Estimated Enrollment: | 75 |
Study Start Date: | January 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals, plus two placebo wafers three times per day with meals
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Drug: Vitamin E, Vitamin C, and Alpha-lipoic Acid
vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg formulated into three capsules, one capsule given three times per day with meals
Drug: Placebo wafers
two placebo wafers three times per day with meals
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2: Experimental
CoQ 400 mg, compounded as a wafer, two wafers three times per day with meals, plus one placebo capsule three times per day with meals
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Drug: Coenzyme Q
400 mg, compounded as a wafer, two wafers three times per day with meals
Drug: Placebo capsules
one placebo capsule three times per day with meals
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3: Placebo Comparator
two placebo wafers three times per day with meals, plus one placebo capsule three times per day with meals
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Drug: Placebo capsules
one placebo capsule three times per day with meals
Drug: Placebo wafers
two placebo wafers three times per day with meals
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Oxidative damage has been shown to be a factor in Alzheimer's disease (AD), and some studies have suggested that supplemental anti-oxidants can decrease the risk of AD or slow its progression. There are many candidate antioxidants, including combinations, which could be neuroprotective in established AD or could have efficacy in the prevention of AD. However, testing each of the possibilities in standard clinical trials is prohibitively expensive. This study will examine antioxidant supplements or vitamins which target specific cellular compartments, and look for evidence of biologically relevant effects in AD by measurement of biomarkers in CSF.
Two general cellular compartments where antioxidant supplements may act are the cytosol and mitochondria. The study will examine a combination of antioxidants that act primarily at cytosolic sites (vitamin E + C + α-lipoic acid) and a single mitochondrial antioxidant, coenzyme Q10.
This multicenter trial will recruit 75 participants who will be randomized into three groups:
The treatment period will last four months. The effects of the two anti-oxidant treatments will be evaluated by measuring biomarkers in blood and cerebrospinal fluid (CSF) at the beginning and end of the 4-month period.
Ages Eligible for Study: | 60 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Note: Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the Project Director.
Excluded Medications:
United States, Arizona | |
University of Arizona | |
Tucson, Arizona, United States, 85724 | |
United States, California | |
University of California, Los Angeles | |
Los Angeles, California, United States, 90095 | |
University of California, San Diego | |
La Jolla, California, United States, 92037 | |
University of California- Irvine | |
Irvine, California, United States, 92697 | |
United States, Florida | |
Wien Center, Mount Sinai Medical Center | |
Miami Beach, Florida, United States, 33140 | |
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536 | |
United States, New Jersey | |
University of Medicine and Dentistry of New Jersey | |
Piscataway, New Jersey, United States, 08855 | |
United States, New York | |
Neurological Care of CNY | |
Syracuse, New York, United States, 13210 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44120 | |
United States, Oregon | |
Oregon Health Sciences University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
Medical University of South Carolina | |
North Charleston, South Carolina, United States, 29406 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98108 |
Principal Investigator: | Douglas Galasko, MD | University of California, San Diego |
Responsible Party: | Alzheimer's Disease Cooperative Study ( Paul Aisen, MD ) |
Study ID Numbers: | IA0067 |
Study First Received: | June 30, 2005 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00117403 |
Health Authority: | United States: Food and Drug Administration |
dementia anti-oxidant biomarkers alpha-tocopherol CoQ |
Tocopherol acetate Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cognition Disorders Coenzyme Q10 Alpha-Tocopherol Tocopherols |
Vitamin E Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Ubiquinone Dementia Ascorbic Acid Thioctic Acid Delirium |
Vitamin B Complex Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins Physiological Effects of Drugs |
Nervous System Diseases Micronutrients Tauopathies Protective Agents Pharmacologic Actions |