An Open-Label Trial of Donepezil in Fragile X Syndrome

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Fragile X syndrome is the most common known inherited cause of neurodevelopmental disability. Functional magnetic resonance imaging (fMRI) studies from our laboratory indicate that specific brain regions using the neurochemical, acetylcholine, show significantly reduced activation during learning. Since donepezil is a medication that enhances acetylcholine function in the brain, the purpose of this study is to determine if donepezil has any beneficial effect on behavior or cognition in subjects with fragile X syndrome.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Donepezil

Criteria

Inclusion Criteria:1. Confirmed genetic diagnosis of fragile X syndrome

2. Age e 14

3. Verbal IQ e 60 Exclusion Criteria:1. Currently taking any anticholinergic medications, tricyclic antidepressant medications, or diphenhydramine.

2. Presence of cardiac disease or bradycardia (< 60 beats/minute) at initial evaluation.