Committee to Identify Neuroprotective Agents for Parkinson’s (CINAPS) Drug Optimization Program

Notice Number: NOT-NS-06-003

Key Dates
Release Date: December 19, 2005

Issued by
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

The National Institute of Neurological Disorders and Stroke (NINDS) has a requirement to accelerate neuroprotective therapeutics development for Parkinson's Disease (PD). PD is the second most commonly occurring neurodegenerative disease, hallmarked by the gradual loss of dopaminergic and other neurons, as well as the accumulation of insoluble aggregates. Therefore, a primary goal is to find rational treatments which can prevent progression of the disease once diagnosed or prevent neurons from dying in individuals at risk for developing the disease.

In 2001, the NINDS established the Committee to Identify Neuroprotective Agents for Parkinson's (CINAPS). CINAPS is the process whereby neuroprotective drugs and doses are selected for the Neuroprotection Exploratory Trials in Parkinson's disease ( NET -PD), which are ongoing. CINAPS has developed an evidence-based approach, which uses the published literature to select promising drugs for Parkinson's clinical trials. This process was well received and the CINAPS results were published (Neurology 60(8):1234-40, 2003). The approach has been adopted for use by the HD and ALS research communities, at their request. While the CINAPS process is sound, the main limitation is the quality and thoroughness of the preclinical animal testing data found in the literature. When planning trials, there is often insufficient information in the published preclinical literature. The models chosen, route of administration, dose and other features may not fully answer some of the questions needed for bringing drugs into clinical trials, or there may simply be no replication of the study results demonstrating efficacy in a particular model. Therefore, NINDS has identified a need to establish a contract facility that would provide resources and capabilities to help select the most promising drugs for PD clinical trials. Some of the tasks involved in this project are: 1) efficacy studies; 2) toxicity studies; 3) PD Animal Model standardization; 4) CINAPS research logistics; and 5) quality control. It is anticipated that one cost-reimbursement type contract will be awarded for a period of five (5) years beginning September, 2006. This is not a Request for Proposals (RFP). Request for Proposals (RFP) No. NIH-NINDS-06-02 will be available electronically and may be accessed through the FedBizOpps (URL: http://www.fedbizopps.gov) or through the NINDS website at the following URL address: (http://www.ninds.nih.gov/funding/funding_announcements/RFP_all.htm) 15 or more calendar days after the issuance of this synopsis. THIS SOLICITATION WILL BE AVAILABLE ELECTRONICALLY ONLY. OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THIS WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED. NO INDIVIDUAL NOTIFICATION OF ANY AMENDMENTS WILL BE PROVIDED. All responsible sources may submit a proposal, which shall be considered by the agency.