FDA concerned on Ampakine animal trials

United Press International, April 13, 2006

Cortex said Thursday it is meeting with the FDA on concerns regarding animal studies of Ampakine, a potential Alzheimer's drug.

The Food and Drug Administration put a hold on Cortex's clinical trial of the drug April 3, a move associated with agency concerns about an investigational drug's safety.

The company said Thursday that it has received a follow-up letter from the Food and Drug Administration outlining the work the company must complete to have the clinical hold removed.

Cortex said it plans to discuss the issues raised in the letter with agency officials "to translate the request into specific acute preclinical studies" related to FDA's concerns and recommendations.

"Cortex is going to cooperate fully with the FDA and work diligently to address its concerns. After the FDA and Cortex have agreed upon a plan of work, the Company will inform shareholders of both the scope of the work involved and the anticipated timeframes for completing such studies," the company said in a statement.

Ampakine is aimed at increasing the strength of signals at connections between brain cells, connections that are believed to deteriorate in people with Alzheimer's disease. This neurotransmitter breakdown causes problems with memory and behavior in these patients.

Last year scientists at Wake Forest University Baptist Medical Center said that primate studies of Ampakine showed the drug improved cognitive performance and also reversed the deleterious effects of sleep deprivation.