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).
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: 1. 25 participants will be given a combination of 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; 2. 25 participants will be given 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; 3. 25 participants will be given both the placebo wafers, two wafers three times per day with meals, plus one placebo capsule three times per day with meals. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
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
400 mg, compounded as a wafer, two wafers three times per day with meals
one placebo capsule three times per day with meals
University of Arizona
Tucson, Arizona, United States
University of California- Irvine
Irvine, California, United States
University of California, San Diego
La Jolla, California, United States
effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage
Time frame: baseline and 4 months
change in plasma and CSF concentrations of a-beta42 and a-beta40
Time frame: baseline and 4 months
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two placebo wafers three times per day with meals
University of California, Los Angeles
Los Angeles, California, United States
Wien Center, Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, United States
Neurological Care of CNY
Syracuse, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
...and 3 more locations