Nationwide study of new Alzheimer drug
Astellas Pharma U.S. has launched a nationwide clinical trial of FK962, an experimental drug for the treatment of Alzheimer's disease. FK962 appears to trigger the release of somatostatin (soh mat uh STAT in) in regions of the brain important in learning and memory.
The trial is designed to test whether stimulating release of somatostatin with different doses of FK962 is safe and may help individuals with mild to moderate Alzheimer's. The study will enroll 510 participants at sites throughout the United States and Canada. Enrollees will receive one of five oral doses of FK962 or a placebo (inactive treatment) for 24 weeks. Medication will be given to each participant's caregiver with instructions on when and how to administer it.
Participants and caregivers will be required to make at least 6 visits to their study site over 26 weeks. Other requirements include the following:
- Participants must not have taken other Alzheimer medications within six weeks of being screened for this study
- Use of certain other medications is also restricted
- At least six blood samples and certain other laboratory tests will be required
Somatostatin is a hormone produced in a number of tissues throughout the body. Its primary role is to block release of other hormones. In the brain it also functions as a neurotransmitter, a specialized messenger chemical that carries information from one nerve cell to another.
Scientists have found that Alzheimer's disease is associated with reduced brain levels of several neurotransmitters, including somatostatin. Laboratory animal research has shown that interfering with somatostatin signaling may cause memory problems and that administering the hormone may benefit memory. In addition, a small human study suggested that somatostatin improved memory for individuals with Alzheimer's disease.
For more details about the study and a list of U.S. and Canadian sites, please visit the National Institute on Aging (NIA) clinical trial index. The toll-free information line for the study is through the Astellas Medical Information Department at 800.727.7003.
For additional background information, please see:
- An abstract of a review article by Gennaro Schettini, M.D., in the April 23, 1991, issue of Pharmacological Research, discussing the normal role of somatostatin in the brain and its impaired function in Alzheimer's disease
- An abstract of the small human study by Suzanne Craft, Ph.D., and colleagues, reported in the Dec. 1999 Archives of General Psychiatry, showing a potential benefit of somatostatin in treating Alzheimer's
- General information on somatostatin from Colorado State University