Effects of CX516 on Functioning in Fragile X Syndrome and Autism

RespireRx

Status and phase

Completed

Phase 2

Conditions

Fragile X Syndrome

Autism

Treatments

Drug: CX516 (Ampalex®)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00054730

CORX-CX516-013

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria