CINAPS is a standardized animal model screening contract to support preclinical assessment of neuroprotective agents for Parkinson’s disease. In the initial phase of this contract, compounds considered for screening were suggested by basic and clinical Parkinson’s disease investigators. The pharmacological agents under consideration had to meet a set of criteria that included:
- targeting of an established mechanism for PD
- demonstrated efficacy in PD animal models, with consistency demonstrated in more than one model
- demonstrated ability to cross the blood brain barrier at therapeutic concentrations
- demonstrated efficacy, safety, tolerability, and identified interactions and kinetics in a human trial
- feasibility for NINDS to pursue a futility study on the compound.
The need for a standardized animal model screening resource arose from the observation that many of the compounds being considered lacked strong preclinical evidence of efficacy. RTI was chosen as the contract research organization for standardized model testing, and under the contract is responsible for
- efficacy and pharmacokinetic studies of drugs, based on gaps in the relevant literature
- toxicity studies on drugs selected, including, if required, the use of additional species other then rodents
- PD animal model standardization, through optimization of animal testing protocols in relevant PD animal models, with the potential for using new experimental models of PD as they become available, over the life time of the contract
- compilation of drug dossiers for the CINAPS advisory committee
- monitoring of quality control across individual screens.