At a glance
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Augmentation of the Cholinergic System in Fragile X Syndrome: A Double-Blind Placebo-Controlled Randomized Study of Donepezil
In Brief
A Phase 2 clinical trial evaluating donepezil and sugar pill for Fragile X Syndrome. Completed, enrolled 45 participants across 1 site.
Detailed Summary
Fragile X syndrome (FraX) is the most common known heritable cause of human intellectual disability. Though recent research has revealed much about the genetic and neurobiological bases of FraX, knowledge about specific and effective treatments for affected individuals is lacking. Based on information from both human and animal studies, one cause of intellectual disability in FraX may be related to deficits in a particular brain neurotransmitter system (the "cholinergic" system). Thus, the investigators propose to use a specific medication, donepezil, to augment cholinergic system in adolescents affected by FraX. If found to be effective, the knowledge generated by this research may also be relevant to other developmental disorders that share common disease pathways with FraX.
Study Details
Timeline
Interventions
donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)