We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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
Information provided by (Responsible Party):

Study Description
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.

Study Design

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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.
Contacts and Locations

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

United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
United States, Florida
Roskamp Institute Memory Clinic
Tampa, Florida, United States, 33617
United States, Georgia
Institute for the Study of Disadvantage and Disability
Atlanta, Georgia, United States, 30342
May South, Inc.
Atlanta, Georgia, United States, 30342
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60608
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9642
United States, Kentucky
Third Age, Inc.
Lexington, Kentucky, United States, 40517
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
United States, New Jersey
Clinical Research Center of New Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
University at Albany, SUNY
Albany, New York, United States, 12222
Nathan Kline Institute
Orangeburg, New York, United States, 10962
George Jervis Clinic
Staten Island, New York, United States, 10314
Westchester Institute for Human Development
Valhalla, New York, United States, 10595
United States, Ohio
University Memory and Aging Center, Case Western Reserve University
Cleveland, Ohio, United States, 44120
Australia, New South Wales
Centre for Developmental Disabilities Studies
Ryde, New South Wales, Australia, 1680
Canada, British Columbia
Down Syndrome Research Foundation
Port Coquitlam, British Columbia, Canada, V3C 2B2
Canada, Ontario
Surrey Place Centre
Toronto, Ontario, Canada, M5S 2C2
Canada, Saskatchewan
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 0M7
United Kingdom
University of Cambridge
Cambridge, England, United Kingdom, CB2 2AH
Greenfields Monyhull Hospital
Kings Norton, Birmingham, England, United Kingdom, B30 3QQ
Kings College: London
London, England, United Kingdom, SE5 8AF
Mercer Institute for Research on Ageing, St. James Hospital
Dublin, Ireland, United Kingdom, 8
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)
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
More Information

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.
Dalton, AJ, Mehta, PD, Fedor, BL, Patti, PJ: Cognitive changes in memory precede those in praxis in aging persons with Down syndrome. Journal of Intellectual and Developmental Disability 24(2):169-187,1999.

Responsible Party: Arthur Dalton, Deputy Director, New York State Institute for Basic Research
ClinicalTrials.gov Identifier: NCT00056329     History of Changes
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:
Alzheimer Disease
Down Syndrome
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action