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Effects of CX516 on Fragile X Syndrome and Autism function

Cortex Pharmaceuticals and the Fraxa Foundation are recruiting patients for a clinical trial on the effects of CX516 on functioning in Fragile X syndrome and Autism. The purpose is to investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X and/or Autism.

Fraxa is a research foundation whose mission is to support research aimed at treatment for Fragile X syndrome.

CX516 is an Ampakine® compound. Ampakine compounds enhance synaptic strength. There is evidence to suggest the synapses in the brain of an individual with Fragile X syndrome are immature and abnormal. CX516 may correct this synaptic transmission defect partially and improve cognitive and behavioral functioning. There is reason to believe these changes caused by CX516 could be helpful in managing cognitive and behavioral symptoms in patients with autistic disorder.

Involvement for each participant will last 28 days. They will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms. The ages eligible for the study: 18-50 years in both genders. All females of childbearing age must have a negative pregnancy test at enrollment. The exclusion criteria is: recent history of seizure, epilepsy, or blackouts; unresolved medical issue impacting performance; behavioral dysfunction to the point that subject can’t cooperate for testing; history of drug-induced neutropenia, and uncontrolled hypertension.

The location and contact information is: California - UC Davis-MIND Institute, Sacramento, CA 95817, Dr. Randi J Hagerman, 1-916-734-6348, cmailto:Randi.hagerman@ucdmc.ucdavis.edu; Illinois - RUSH-Presbyterian-St. Luke's Medical Center, Chicago, IL 60612, Dr.
Elizabeth M. Berry-Kravis, 1-312-942-4036, Elizabeth_M_Berry-Kravis@rush.edu.

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