Anti-Oxidant Treatment of Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): Vitamin E, Vitamin C, and Alpha-lipoic Acid; Coenzyme Q; Placebo capsules; Placebo wafers
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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; two placebo wafers three times per day with meals
Intervention MeSH terms: Vitamins; Vitamin E; Thioctic Acid; Coenzyme Q10; Ubiquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: dementia; anti-oxidant; biomarkers; alpha-tocopherol; CoQ