Vitamin E in Aging Persons With Down Syndrome

• Status: Unknown status
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Institute for Basic Research
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Complementary and Integrative Health (NCCIH); National Institute on Aging (NIA)
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

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.