Vitamin E in Aging Persons With Down Syndrome

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: Down Syndrome, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00056329

Run by

New York State Institute for Basic Research

People needed

350

Starts

2002-04-01

Expected to finish

2012-05-01

Last updated by the study team

2012-05-04

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Connecticut Health Center — Farmington, Connecticut, United States
• Roskamp Institute Memory Clinic — Tampa, Florida, United States
• Institute for the Study of Disadvantage and Disability — Atlanta, Georgia, United States
• May South, Inc. — Atlanta, Georgia, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Third Age, Inc. — Lexington, Kentucky, United States
• McLean Hospital — Belmont, Massachusetts, United States
• Clinical Research Center of New Jersey — Voorhees Township, New Jersey, United States
• University at Albany, SUNY — Albany, New York, United States
• Nathan Kline Institute — Orangeburg, New York, United States
• George Jervis Clinic — Staten Island, New York, United States
• Westchester Institute for Human Development — Valhalla, New York, United States
• University Memory and Aging Center, Case Western Reserve University — Cleveland, Ohio, United States
• Centre for Developmental Disabilities Studies — Ryde, New South Wales, Australia
• Down Syndrome Research Foundation — Port Coquitlam, British Columbia, Canada
• Surrey Place Centre — Toronto, Ontario, Canada
• Saskatoon City Hospital — Saskatoon, Saskatchewan, Canada
• University of Cambridge — Cambridge, England, United Kingdom
• Greenfields Monyhull Hospital — Kings Norton, Birmingham, England, United Kingdom
• Kings College: London — London, England, United Kingdom
• Mercer Institute for Research on Ageing, St. James Hospital — Dublin, Ireland, United Kingdom

Full record on ClinicalTrials.gov

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