January 22, 2003

Individuals with mild cognitive impairment (MCI) and those with early Alzheimer's disease may be eligible for two investigational studies of new medications.

Information on the two studies, which will be held at the Alzheimer's Disease Research Center (ADRC) of the University of California, San Diego (UCSD) School of Medicine, is available by calling Karen Wetzel at the ADRC, 858-622-5800.

A progressive disease characterized by death of nerve cells in several areas of the brain, resulting in loss of memory, Alzheimer's disease is the most common type of dementia. Symptoms include gradual memory loss, decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss of language skills, impairment of judgment and planning and personality changes. Eventually patients become totally incapable of caring for themselves.

Mild Cognitive Impairment (MCI) is a condition characterized by mild recent memory loss without dementia or significant impairment of other cognitive functions as seen in patients with Alzheimer's disease.

The UCSD studies are:

Although donepezil is already marketed for Alzheimer's disease (AD) at doses of 5-10 mg/day, doses above 10 mg/day have not been studied and are considered investigational. The reason for this study is to find out more about the safety and effectiveness of 15mg/day and 20mg/day of donepezil in patients with mild to moderate AD. Everyone in the study will receive at least 10mg/day of donepezil. Study participation will last about 6 months. There will be no payment for participation in this study; however, all tests, examinations, and medical care required, as part of this study will be provided at no cost to the subject.

The reason for this study is to determine whether the investigational drug, CX516 (Ampalex®), is safe, well tolerated, and effective for use in patients with mild cognitive impairment. This study will evaluate one dose level of CX516 administered by mouth for 4 weeks compared to a placebo (an inactive substance). Study participation will last about 8 weeks. All tests, examinations, and medical care required as a part of this study will be provided at no cost to the subject. Subjects will be paid a compensation for travel expenses incurred if they complete the study.

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News Media Contact:
Sue Pondrom
619-543-6163
spondrom@ucsd.edu

UCSD Health Sciences Communications Healthbeat:http://health.ucsd.edu/news/