Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117403
Status:
COMPLETED
Last Update Posted:
2009-04-03
First Post:
2005-06-30
Brief Title:
Anti-Oxidant Treatment of Alzheimers Disease
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Evaluation of the Safety Tolerability and Impact on Biomarkers of Anti-Oxidant Treatment of Mild to Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 Alzheimers 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None