Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Completed · Phase 2
Conditions studied: Fragile X Syndrome, Autism
In brief
This study will investigate whether CX516 can improve attention, memory, language, or behavior in adults with Fragile X Syndrome and/or Autism. CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is evidence to suggest that the synapses in the brain of an individual with fragile X syndrome are immature and abnormal. It is possible CX516 may partially correct this synaptic transmission defect and lead to improvement in cognitive and behavioral functioning. There is also reason to believe that 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. Participants will be given study medication, a physical exam, and a variety of cognitive assessment tests to study potential drug effectiveness at improving disease symptoms.
Key facts
- Study ID
- NCT00054730
- Run by
- RespireRx
- Starts
- 2002-06-01
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Fragile X group
- DNA-based diagnosis of Fragile X syndrome
- Autism group
- Documented diagnosis with ADOS; ADI-R; CARS and GARS
- Both groups
- 18-50 years
- Measured IQ below 85
- Measured IQ >20
- Mental age >30 months
- Stable medication regimen for past 8 weeks
- Normal hearing
- Vision corrected to at least 20/50
- All females of childbearing age must have a negative pregnancy test at enrollment
You may not qualify if…
- Recent history of seizure, epilepsy, or blackouts
- Unresolved medical issue impacting performance
- Behavioral dysfunction to the point that subject cannot cooperate for testing
- History of drug-induced neutropenia
- Uncontrolled hypertension
Where it is running
- UC Davis-MIND Institute — Sacramento, California, United States
- RUSH-Presbyterian-St. Luke's Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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