Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056329
Status:
UNKNOWN
Last Update Posted:
2012-05-04
First Post:
2003-03-10
Brief Title:
Vitamin E in Aging Persons With Down Syndrome
Sponsor:
New York State Institute for Basic Research
Organization:
New York State Institute for Basic Research
Study Overview
Official Title:
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
Status:
UNKNOWN
Status Verified Date:
2012-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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 goal of this study is to determine the safety and efficacy of the administration of vitamin E which has been shown to delay the progression of Alzheimers disease in slowing the rate of cognitivefunctional decline in older persons with Down syndrome
Detailed Description:
The growing success of therapeutic interventions including the antioxidant Vitamin E for Alzheimers disease in the general population requires a solution to the methodological problems so that therapeutic trials can be conducted in the aging population with Down syndrome which will ultimately improve their quality of life as well as that of their families and caregivers The experience gained in this trial will be useful to the design of appropriate cognitive measures of Alzheimers disease in persons with Down syndrome in subsequent trials
The goal of this international three-year study is to determine whether the administration of vitamin E which has been shown to delay the progression of Alzheimers disease will slow the rate of cognitivefunctional decline in persons age 50 or older with Down syndrome Persons with Down syndrome functioning at all levels of intellectual disability will be eligible Men and women of approximately equal numbers and people from minorities and ethnic groups other than Caucasian will be included A total of 350 individuals with Down syndrome 50 years of age and older have been recruited at approximately 21 trial sites The study is a randomized double-blind placebo-controlled parallel group design with stratification by geographic site and presence of Alzheimer disease according to DSM-IV American Psychiatric Association criteria for diagnosing this disease
Apolipoprotein E Apo E genotype will be determined at the screening visit to allow secondary analyses of the impact of Apo E genotype that may influence Alzheimers disease risk on outcome measures and the response to treatment DNA specimens will also be stored for possible future genetic analyses with trial sites allowing for non-participation in this procedure Visits will occur at baseline and then at 6 monthly intervals with each visit including interval medical history current and interval medications side effects checklist adverse events pill count institutionalization status cognitive functional and behavioral measures and DSM-IV diagnostic assessment for Alzheimers disease
The goal of this international three-year study is to determine whether the administration of vitamin E which has been shown to delay the progression of Alzheimers disease will slow the rate of cognitivefunctional decline in persons age 50 or older with Down syndrome Persons with Down syndrome functioning at all levels of intellectual disability will be eligible Men and women of approximately equal numbers and people from minorities and ethnic groups other than Caucasian will be included A total of 350 individuals with Down syndrome 50 years of age and older have been recruited at approximately 21 trial sites The study is a randomized double-blind placebo-controlled parallel group design with stratification by geographic site and presence of Alzheimer disease according to DSM-IV American Psychiatric Association criteria for diagnosing this disease
Apolipoprotein E Apo E genotype will be determined at the screening visit to allow secondary analyses of the impact of Apo E genotype that may influence Alzheimers disease risk on outcome measures and the response to treatment DNA specimens will also be stored for possible future genetic analyses with trial sites allowing for non-participation in this procedure Visits will occur at baseline and then at 6 monthly intervals with each visit including interval medical history current and interval medications side effects checklist adverse events pill count institutionalization status cognitive functional and behavioral measures and DSM-IV diagnostic assessment for Alzheimers disease
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIA Grant AG16381 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AG016381 |
| R01AG016381 | NIH | None | None |