Stanford / VA / NIA Aging Clinical Research Center
Palo Alto Veterans Health Care System
3801 Miranda Ave 151Y, Palo Alto, CA 94304
Phone: 650-852-3287 Fax: 650-852-3297
http://alzheimer.stanford.edu

 

The Cholesterol Lowering Agent to Slow Progression of Alzheimer’s Disease (CLASP) Study: Questions & Answers

What is the CLASP Study?
CLASP is a research study to investigate the safety and effectiveness of simvastatin (a cholesterol lowering drug or statin) to slow the progression of Alzheimer’s disease (AD). Statins are commonly used to treat high cholesterol levels, which increase the risk of heart disease and stroke.

CLASP is sponsored by the Alzheimer’s Disease Cooperative Study and funded by the U.S. Government’s National Institute on Aging, one of the National Institutes of Health.

Why study cholesterol lowering drugs (statins) for Alzheimer’s disease?
In studies in animals and humans, researchers found that lowering cholesterol levels with statins seems to have a positive impact on brain function and reduces the risk of AD. The CLASP trial will test the link between using a cholesterol lowering medication and slowing disease progress in people with mild to moderate AD.

Who can participate in the CLASP trial?
We are looking for volunteers who:
· have mild to moderate AD
· are age 50 or older
· speak English or Spanish
· do not currently take or need cholesterol lowering drugs
· have a study partner – a friend or relative who can accompany the volunteer to all clinic visits and answer questions about him/her.

What will study volunteers be asked to do?
· Be evaluated to determine if your cholesterol is in the normal range and if you are eligible for our study.
· Take a prescribed dose of the study drug* daily for 18 months (volunteers will receive all study medications free of charge).
· Go to the study clinic for screening, monitoring, and testing a total of 8 times over the course of the 21-month study.
Study partners will be asked to come with volunteers on all clinic visits, and answer questions about the volunteer’s health status.

*This is a randomized, placebo-controlled study. Half of participants will be assigned at random to receive the experimental drug, the other half will receive placebo (inactive pill).

How safe is the study drug?
Simvastatin (brand name Zocor) has been safety tested among more than 21,000 people, and found to have few side effects or adverse reactions. All study participants will be closely monitored for any problems with the drug.

Will study volunteers still see their regular doctors?
Yes. Participation in the study will not replace visits to your regular physician.

What are the benefits of participating in CLASP?
By participating in CLASP, volunteers will:
· Get a free cholesterol screening and be referred for treatment if needed.
· Contribute to our understanding of a drug that may be a new treatment for AD.
· Get regular assessment by physicians and qualified health care professionals who specialize in Alzheimer’s disease.


For more information, or to volunteer, contact:

Shannon Hsu at (650) 493-5000 ext. 63890 or
Lisa Kinoshita, PhD at (650) 493-5000 ext. 65633


© 2004 Stanford/VA/NIA Aging Clinical Research Center