Multicenter Vitamin E Trial in Persons with Down Syndrome
Third Age, Inc. has been selected to participate in the first international clinical trial on the impact of Vitamin E on short term memory for people with Down syndrome. Dr. Arthur Dalton of the Basic Institute on Research in New York City is the Co-Director and supervises the project activities for Third Age. There are 20 sites around the country and in Canada, England, and Australia that are participating in this study. Studies involving people with Alzheimer's disease has demonstrated that high dosages of Vitamin E may off-set the lost of short-term memory for some years providing the participants a slowing of the onset of memory loss.
This project recruits participants who are 50 years old or older, and have Down syndrome to take two Vitamin E capsules a day (one in the morning and one at night) or a placebo and a multivitamin for thirty-six months. This is a double blind research project where half of the participants will be given 2000 IUs of Vitamin E and multivitamins and half will take a placebo and multivitamin provided by the Roche Company. No one will know who is getting the high doses of Vitamin E and who is getting the placebo. Every six months, memory testing will occur using six easily conducted tests that will take less than 45 minutes for the participants.
There are four stages to the project over a thirty-six month period:
Stage I. Recuriting and Consent to participant.
Stage II. Initial screening with reporting of medical/health status information and a basic physical examination. A preliminary screening evaluation included the following:
- Interview with informant/caregiver
- Review of medical history and current medications
- Physical examination
- Modified Hachinski
- Laboratory studies (valid if done within the past six months).
- Brief Praxis Test
Stage III. Base line testing of short-term memory using five applications. These activities will be repeated at six-month intervals.
- Brief Praxis Test
- Modified Fuld Memory Test
- New Dot Test
- Expressive Vocabulary Test
- Orientation Test
- Review of concurrent medications with caregiver.
- Brief physical examination will be conducted at each six-month stage.
- Receive the six-month supply of vitamins. Additional supplies will be renewed at six-month intervals.
A quarterly phone contact will be conducted to see how the participant is doing and if there are changes in the participant's health or living situation.
Stage IV. The final visit will include a physical examination like the initial screening, collection of a blood sample, and memory tests as conducted previously. Third Age will cover the cost of the basic physical exams and the blood work when necessary.
The U. S. Department of Health and Human Services has approved Third Age Inc. as a Federal Wide Assurance for Human Subjects Protection agency. Our "institute identifier" is FWA-00000842.
The New York Institute for Basic Research (IBR) reviews and approves our required Institutional Review Board (IRB) application annually.
For more information or to see if you can participate, call 859-523-1776.