Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
NCT ID: NCT00935493
Last Updated: 2014-08-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2009-06-30
2012-08-31
Brief Summary
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Detailed Description
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* To determine whether low does of the α2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated working memory and executive control functions, in healthy elderly subjects. Subjects will be randomly assigned to receive placebo or guanfacine at one of two dose levels: 0.1 mg, or 0.5 mg daily at bedtime in double-blind fashion for twelve weeks.
Secondary:
* To determine whether guanfacine can favorably influence global status and quality of life (QOL) in healthy elderly subjects.
* To determine whether low-dose guanfacine is safe and well-tolerated in healthy elderly subjects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Guanfacine 0.1 mg po qhs
Guanfacine
Guanfacine 0.1 mg po qhs
Guanfacine 0.5 mg po qhs
Guanfacine
Guanfacine 0.5 mg po qhs
Placebo po qhs
Placebo
Placebo po qhs
Interventions
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Guanfacine
Guanfacine 0.1 mg po qhs
Guanfacine
Guanfacine 0.5 mg po qhs
Placebo
Placebo po qhs
Eligibility Criteria
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Inclusion Criteria
* Fluent in English
* Stable medical condition for at least 4 weeks prior to Screening visit
* Stable dose of non-excluded medications for at least 4 weeks prior to Screening visit
Exclusion Criteria
* Mild Cognitive Impairment (Amnestic MCI)
* Clinically significant neurologic disease
* Clinically significant or unstable medical conditions that would interfere with participation in the trial
* Known hypersensitivity to guanfacine
* History of alcohol or substance abuse or dependence within the past 5 years
* Active major psychiatric disorders, including major depression
* History of mental retardation
* Significant abnormalities on clinical laboratories, ECG, or physical examination
* Impairment of visual or auditory acuity sufficient to interfere with completion of study procedures
* Education level \< 6 years
75 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Christopher H van Dyck, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Alzheimer's Disease Research Unit, Yale University School of Medicine
New Haven, Connecticut, United States
Countries
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Other Identifiers
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R01-030457-1
Identifier Type: -
Identifier Source: secondary_id
0805003881
Identifier Type: -
Identifier Source: org_study_id
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