RespireRx Pharmaceuticals Inc (RSPI)

[Aiming4]

Old News: Servier CX-516 MCI trial:

Servier still has this link on their website... Aiming4.

About the Trial

This seminal trial will evaluate the safety and efficacy of AMPAKINE CX516 in approximately 160 patients with MCI who are between the ages of 55 and 85. Patients will be randomized to receive placebo or the AMPAKINE CX516 for a period of four weeks. The trial is double-blind. CORTEX has overall responsibility for the conduct of the trial, which is being co-managed by CORTEX and SERVIER. Separately, CORTEX previously received funding from the Institute for the Study of Aging (the "Institute") to offset part of its clinical cost. The Institute is a non-profit foundation based in New York City dedicated to the improvement in quality of life for the elderly.

Enrollment in the study will commence in various countries during the first quarter of 2002 as regulatory approvals are obtained. The diagnostic procedures, as well as the primary and secondary outcome measures, were agreed upon by an International Scientific Advisory Committee last May in conjunction with the American Association of Neurology meeting in Philadelphia. This Advisory Committee was composed of neurological experts from the United States and Europe and was supported by a grant-in aid from CORTEX and SERVIER.

"The response by clinicians invited to participate in the trial has exceeded our expectations, resulting in more centers than we initially anticipated,'' said Vincent Simmon, Ph.D., President and CEO of CORTEX. "This could lead to more rapid enrollment. Assuming we complete enrollment during January 2002, we anticipate completing a preliminary evaluation during the second quarter of 2003."

This cross-national 28-day trial will evaluate the ability of patients to recall a list of 15 words 30 minutes after they have practiced learning the list. Other endpoints will include evaluation by their clinician for improvement, evaluation on a clinical rating scale for dementia, and a small battery of neuropsychiatric tests, in addition to an assessment of safety. The primary end point will be on the last day of treatment. However, patients will also return for a final evaluation approximately two weeks after their last treatment. "We have previously observed that this class of compounds has the ability to promote improvements that may last for several weeks,"' commented Dr. Simmon. "Needless to say, we are interested to see if those earlier observations can be repeated in patients with MCI."

http://www.servier.com/pro/html_news_home/cortex_trial.asp