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Vitamin E in Aging Persons With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00056329
Recruitment Status : Unknown
Verified May 2012 by Arthur Dalton, New York State Institute for Basic Research.
Recruitment status was:  Active, not recruiting
First Posted : March 12, 2003
Last Update Posted : May 4, 2012
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Arthur Dalton, New York State Institute for Basic Research

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.

Condition or disease Intervention/treatment Phase
Down Syndrome Alzheimer Disease Drug: Vitamin E Drug: multivitamin Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Vitamin E Trial in Aging Persons With Down Syndrome
Study Start Date : April 2002
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012


Arm Intervention/treatment
Experimental: 1
vitamin E plus multivitamin
Drug: Vitamin E
1,000 international units twice daily for three years
Other Name: tocopherol

Drug: multivitamin
once daily for three years

Placebo Comparator: 2
placebo with multivitamin
Drug: multivitamin
once daily for three years

Drug: Placebo
Placebo twice daily for three years




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056329


Locations
Show Show 22 study locations
Sponsors and Collaborators
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 Integrative Health (NCCIH)
Investigators
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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 Icahn School of Medicine at Mount Sinai

Publications of Results:
Sano M, Aisen PS, Dalton AJ, Andrews HF, Tsai W-Y, and the International Down Syndrome Alzheimer Disease Consortium. Assessment of aging individuals with Down syndrome in clinical trials: results of baseline measures. Journal of Policy and Practice in Intellectual Disabilities. 2005 2(2):126-138.

Other Publications:
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Responsible Party: Arthur Dalton, Deputy Director, New York State Institute for Basic Research
ClinicalTrials.gov Identifier: NCT00056329    
Other Study ID Numbers: IA0039
R01AG016381 ( U.S. NIH Grant/Contract )
NIA Grant AG16381
First Posted: March 12, 2003    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012
Keywords provided by Arthur Dalton, New York State Institute for Basic Research:
Aging Persons
Down Syndrome
Vitamin E
Alzheimer disease
Additional relevant MeSH terms:
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Alzheimer Disease
Down Syndrome
Syndrome
Disease
Pathologic Processes
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants