Vitamin E in Aging Persons With Down Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by New York State Institute for Basic Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Arthur Dalton, New York State Institute for Basic Research
ClinicalTrials.gov Identifier:
NCT00056329
First received: March 10, 2003
Last updated: May 2, 2012
Last verified: May 2012

March 10, 2003
May 2, 2012
April 2002
May 2012   (final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00056329 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Vitamin E in Aging Persons With Down Syndrome
Multicenter Vitamin E Trial in Aging Persons With Down Syndrome

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Down Syndrome
  • Alzheimer Disease
  • Drug: Vitamin E
    1,000 international units twice daily for three years
    Other Name: tocopherol
  • Drug: multivitamin
    once daily for three years
  • Drug: Placebo
    Placebo twice daily for three years
  • Experimental: 1
    vitamin E plus multivitamin
    Interventions:
    • Drug: Vitamin E
    • Drug: multivitamin
  • Placebo Comparator: 2
    placebo with multivitamin
    Interventions:
    • Drug: multivitamin
    • Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
350
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States,   Canada,   United Kingdom
 
NCT00056329
IA0039, R01AG016381, NIA Grant AG16381
Yes
Arthur Dalton, New York State Institute for Basic Research
New York State Institute for Basic Research
  • National Institute on Aging (NIA)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Complementary and Alternative Medicine (NCCAM)
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
New York State Institute for Basic Research
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP