Allan L. Reiss
An Open-Label Trial of Donepezil in Fragile X Syndrome
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Donepezil
Phase:
Phase 1Eligibility
Ages Eligible for Study:
14 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Confirmed genetic diagnosis of fragile X syndrome
2. Age e 14
3. Verbal IQ e 60
Key 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.
Additional Study Details
Official Title:
An Open-Label Trial of Donepezil in Fragile X SyndromeAnticipated start date:
Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Scores on working memory tests at baseline, day 21, & day 42
- Scores on learning tests at baseline, day 21, & day 42
- Score on test of attention at baseline, day 21, & day 42
- Scores on measures of behavior at baseline, day 21, & day 42
Total Number to be Enrolled:
10Total Number to be Enrolled at Stanford:
0More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
8/6/2007PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help