Vitamin E in Aging Persons With Down Syndrome - Tabular View

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Vitamin E in Aging Persons With Down Syndrome

This study is ongoing, but not recruiting participants.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Vitamin E in Aging Persons With Down Syndrome

Official Title ^†

Multicenter Vitamin E Trial in Aging Persons With Down Syndrome

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 Alzheimer's disease, in slowing the rate of cognitive/functional decline in older persons with Down syndrome.

Detailed Description

The growing success of therapeutic interventions (including the antioxidant Vitamin E) for Alzheimer's 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 Alzheimer's 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 Alzheimer's disease, will slow the rate of cognitive/functional 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 Alzheimer's 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 Alzheimer's disease.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Brief Praxis Test, measuring cognitive functions expressed as performances of simple, short, sequences of voluntary movements [ Time Frame: Screening, Baseline, every 6 months for 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measure ^†

Fuld Object Memory Test (Modified), New Dot Test, Orientation Test, Vocabulary Test, Behavior & Function Down Syndrome Rating Scale, Clinical Global Impression of Change (CGI-C) [ Time Frame: Screening, Baseline, and every 6 months for 36 months ] [ Designated as safety issue: No ]

Condition ^†

Down Syndrome
Alzheimer Disease

Intervention ^†

Drug: Vitamin E
Drug: multivitamin
Drug: Placebo

MEDLINE PMIDs

9110909, 9153159, 9161927

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

350

Start Date ^†

April 2002

Completion Date

August 2010

Eligibility Criteria ^†

Inclusion Criteria:

Presence of clinically determined Down syndrome (karyotypes optional).
Medically stable.
Medications stable over 3 months.
Appropriately signed and witnessed consent form.
Involvement/cooperation of informant/caregiver.

Exclusion Criteria:

Medical/neurological condition (other than Alzheimer's disease) associated with dementia.
Brief Praxis Test score <20.
Modified Hachinski score >4.
Major depression within 3 months.
History of any disorder of blood coagulation (inherited or acquired).
Current use of anti-coagulants.
Use of experimental medications within 3 months.
Regular use of vitamin E greater than 50 units per day during the previous 6 months.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Canada, United Kingdom

Administrative Information Fields

NCT ID ^†

NCT00056329

Organization ID

IA0039

Secondary IDs ^††

NIA Grant AG16381

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Alternative Medicine (NCCAM)

Investigators ^†

Principal Investigator:	Arthur J Dalton, PhD	New York State Institute for Basic Research in Developmental Disabilities
Study Director:	Paul S Aisen, MD	Georgetown University
Study Director:	Mary C Sano, PhD	Mount Sinai School of Medicine

Information Provided By

National Institute on Aging (NIA)

Verification Date

February 2008

First Received Date ^†

March 10, 2003

Last Updated Date

February 20, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.