NCT00220584

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

4 years

First QC Date

September 15, 2005

Last Update Submit

December 11, 2012

Conditions

Fragile X Syndrome

Outcome Measures

Primary Outcomes (5)

  • Scores on learning tests at baseline

    baseline, day 21, day 42

  • score on test of attention

    baseline, day 21, day 42

  • score on measures of behavior

    baseline, day 21, day 42

  • scores on learning tests

    baseline, day 21, day 42

  • scores on working memory tests

    baseline, day 21, day 42

Study Arms (1)

Open donepezil

EXPERIMENTAL

open donepezil

Drug: donepezil

Interventions

donepezilDRUG

donepezil 5 mg daily for 3 weeks (days 1-21); 10 mg daily for 3 weeks (days 22-42)

Also known as: Aricept, donepezil hydrochloride
Open donepezil

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age e 14

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Fragile X Syndrome

Interventions

Donepezil

Condition Hierarchy (Ancestors)

X-Linked Intellectual DisabilityIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGenetic Diseases, X-LinkedHeredodegenerative Disorders, Nervous System

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Allan L Reiss

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

US(1)