Scientific Consulting Services for the Phenomenological Study on Autism and Immune Dysfunction

This is a notice of intent, not a request for a proposal. A solicitation document will not be issued and proposals will not be requested. National Institute on Drug Abuse, Office of Acquisitions- Neurosciences, Station Support/Simplified Acquisition, on behalf of the National Institute of Mental Health (NIMH) intends to negotiate and award a purchase order on a noncompetitive basis to Johns Hopkins University. The Pediatrics and Developmental Neurosciences (PDN) Branch is involved in a large phenomenological study focusing on the interrelationship between regression in autism and immune dysfunction. The NIMH proposes to conduct a longitudinal natural history study of 50 children with autism and strictly defined regression, 50 children with autism and no history of regression, 50 typically developing children, and 25 children who meet criteria for Retts Disorder (a genetic disorder in which children have autistic features with clear regression). Subjects will be 12 to 48 months of age at study entry in order to capture regression as close to its onset as possible. Systematic prospective evaluations will be utilized in order to provide validation to the phenomenon of regression in autism, determine diagnostic and functional outcomes, and evaluate behavioral, medical and immunologic functioning. The period of performance is 12 months with an option for up to 2 option years. The ofjective is to 1. To characterize and validate the regressive phenotype in children with autism. 2. To characterize the immune response in children with autism. a. Distinct immunologic responses and cytokines abnormalities will be evident in children in the regressive autism sample, but not in the non-regressive autism, Retts Disorder, or typically developing samples. 3. To identify neurobiologic markers for autism through the techniques of metabolomics, proteomics and genomics (e.g. gene expression profiles). In addition, based on evidence of a pro-inflammatory profile seen in autism from the lab of Dr. Carlos Pardo. NIMH have designed a treatment trial using the anti-inflammatory properties of minocycline. Efficacy will be tested by examining the cytokine and chemokine profiles of serum and cerebrospinal fliud (CSF) before and after treatment. Dr. Pardo and the Neuriommunology Laboratory at Johns Hopkins has pioneered this line of investigation in autism. No other laboratory is doing these types of analysis on CSF in autism. The acquisition is being conducted under simplified acquisition using FAR 12 procedures and cites FAR 6.302-1. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely with the discretion of the Government.