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| Descriptive Information Fields | |||||
| Brief Title † | Anti-Oxidant Treatment of Alzheimer's Disease | ||||
| Official Title † | Evaluation of the Safety, Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimer's Disease | ||||
| Brief 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). |
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| 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:
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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | effect on cerebrospinal fluid (CSF) biomarkers related to oxidative damage [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | change in plasma and CSF concentrations of a-beta42 and a-beta40 [ Time Frame: baseline and 4 months ] [ Designated as safety issue: No ] | ||||
| Condition † | Alzheimer's Disease | ||||
| Intervention † | Drug: Vitamin E, Vitamin C, and Alpha-lipoic Acid Drug: Coenzyme Q Drug: Placebo capsules Drug: Placebo wafers |
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| MEDLINE PMIDs | 9110909, 10096843, 14732624 | ||||
| Links | ADCS Anti-Oxidant Study webpage ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 75 | ||||
| Start Date † | January 2006 | ||||
| Completion Date | September 2007 | ||||
| Eligibility Criteria † | 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:
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| Gender | Both | ||||
| Ages | 60 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00117403 | ||||
| Organization ID | IA0067 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | Alzheimer's Disease Cooperative Study (ADCS) | ||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | June 30, 2005 | ||||
| Last Updated Date | April 15, 2008 | ||||