What I am telling you is this. They are not doing this because they have not seen anecdotal evidence to support the idea that this approach has merit. What I am telling you is that these materials are safe and non-toxic. I am saying, help your friends/relatives in any way you can, some may not have the time to wait until this study goes through three phases.... 4Mor
http://clinicaltrials.gov/ct/gui/show/NCT00117403?order=5Condition Intervention Phase
Alzheimer's Disease
Drug: Vitamin E
Drug: Vitamin C
Drug: Alpha-lipoic acid
Drug: Coenzyme Q
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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
Further Study Details:
Primary Outcomes: effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage
Secondary Outcomes: change in plasma and CSF concentrations of a-beta42 and a-beta40
Expected Total Enrollment: 75
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:
25 participants will be given a combination of vitamin E 800 IU, vitamin C 200 mg, and alpha-lipoic acid 600 mg compounded as a single capsule, once per day, plus two placebo wafers three times per day with meals;
25 participants will be given CoQ 400 mg, compounded as a wafer, two wafers three times per day with meals, plus one placebo capsule per day;
25 participants will be given both the placebo wafers, two wafers three times per day with meals, plus one placebo capsule per day.
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.