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Randomized Controlled Study of Donepezil in Fragile X Syndrome

NCT01120626 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-03-17

Study results available
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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.

Conditions

  • Fragile X Syndrome

Interventions

DRUG

donepezil

donepezil (2.5 mg to 10.0 mg per day for 12 weeks)

DRUG

sugar pill

sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Autism Speaks

    collaborator OTHER

  • Stanford University

    lead OTHER

Principal Investigators

  • Allan L Reiss · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120626 on ClinicalTrials.gov