Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056225
Status:
COMPLETED
Last Update Posted:
2009-06-12
First Post:
2003-03-07
Brief Title:
VITAL - VITamins to Slow ALzheimers Disease Homocysteine Study
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
High Dose Supplements to Reduce Homocysteine and Slow the Rate of Cognitive Decline in Alzheimers Disease Vitamins to Slow Alzheimers - VITAL
Status:
COMPLETED
Status Verified Date:
2009-06
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 determine whether reduction of homocysteine levels with high-dose folate folic acid B6 and B12 supplementation will slow the rate of cognitive decline in persons with Alzheimers disease
Detailed Description:
Blood levels of homocysteine are elevated in Alzheimers disease AD and hyperhomocysteinemia may contribute to disease pathophysiology by vascular and direct neurotoxic mechanisms Homocysteine levels can be reduced by administration of high dose supplements of folate folic acid and vitamins B6 and B12 The proposed study is for a multicenter randomized controlled clinical trial to determine whether reduction of homocysteine levels with high-dose folateB6B12 supplementation will slow the rate of cognitive decline in subjects with AD
This will be a parallel design study including two groups of unequal size 60 of subjects will receive daily high-dose supplements folate 5mg vitamin B6 25mg vitamin B12 1 mg and 40 will receive an identical looking placebo The duration of treatment will be 18 months and participants will make eight visits to the assigned study site for safety and efficacy assessments of the medications The primary outcome measure will be the longitudinal decline in the ADAScog a psychometric instrument that evaluates memory attention reasoning language orientation and praxis Rosen et al 1984 To power the trial to detect a 25 reduction in rate of ADAScog decline 80 power alpha005 drop-out estimate 20 drop-in estimate 10 it will enroll a total of 400 participants Persons of minority racial groups are also being recruited although all participants must be able to speak either English or Spanish
This will be a parallel design study including two groups of unequal size 60 of subjects will receive daily high-dose supplements folate 5mg vitamin B6 25mg vitamin B12 1 mg and 40 will receive an identical looking placebo The duration of treatment will be 18 months and participants will make eight visits to the assigned study site for safety and efficacy assessments of the medications The primary outcome measure will be the longitudinal decline in the ADAScog a psychometric instrument that evaluates memory attention reasoning language orientation and praxis Rosen et al 1984 To power the trial to detect a 25 reduction in rate of ADAScog decline 80 power alpha005 drop-out estimate 20 drop-in estimate 10 it will enroll a total of 400 participants Persons of minority racial groups are also being recruited although all participants must be able to speak either English or Spanish
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