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Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00935493
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : August 11, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
This proposal aims to determine whether low does of the alpha-2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated cognitive functions in healthy elderly subjects.

Condition or disease Intervention/treatment Phase
Cognitive Aging Drug: Guanfacine Drug: Placebo Not Applicable

Detailed Description:

Primary:

  • 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Study Start Date : June 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Guanfacine 0.1 mg po qhs Drug: Guanfacine
Guanfacine 0.1 mg po qhs
Experimental: Guanfacine 0.5 mg po qhs Drug: Guanfacine
Guanfacine 0.5 mg po qhs
Placebo Comparator: Placebo po qhs Drug: Placebo
Placebo po qhs


Outcome Measures
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Primary Outcome Measures :
  1. Mean in the Prefrontal Executive Function Z-score (PEF6_6) [ Time Frame: 12 weeks ]

    The primary outcome measure (PEF6_Z) is the mean of z-scores for 6 executive function tasks (CANTAB: Spatial Working Memory, Stockings of Cambridge, Intradimensiona/Extradimensional Shift, Paired Associates Learning; Stroop Color Word Score, Trail Making Test - B).

    The score is composed of six component scales coded as z scores that measures cognitive functioning in which higher scores represent better cognitive functioning; therefore, the least squares means listed here represent mean outcome changes from baseline



Secondary Outcome Measures :
  1. Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 12 weeks ]
    The seven-point scale was collapsed into 3 groups and coded as a three-level ordinal scale of global status, representing ordered levels of worse (including minimally, moderately and markedly worse), unchanged, and improved (including minimally, moderately, and markedly improved) global status.

  2. Quality of Life (SF-36 MCS) [ Time Frame: 12 weeks ]

    Quality of Life (QOL) was assessed using the SF-36 (36-Item Short-Form Health Survey; QualityMetric, Lincoln, RI), MCS subscale. The SF-36 is a self-administered general health-related quality of life scale with 36 items. The MCS subscale has been shown to be responsive in psychoactive drug trials. The score range is 0-100.

    Higher scores represent better mental health; therefore, the least squares means listed here represent mean outcome changes from baseline.



Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects enrolled will be nondemented, male and female individuals who meet the following inclusion criteria:

  • 75 years of age or older
  • 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:

  • Dementia
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00935493


Locations
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United States, Connecticut
Alzheimer's Disease Research Unit, Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Christopher H van Dyck, MD Yale University
More Information
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Additional Information:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00935493    
Other Study ID Numbers: 0805003881
R01-030457-1
First Posted: July 9, 2009    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Yale University:
guanfacine
aging
cognitive aging
 prefrontal cognitive function
executive function
prefrontal cortex
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
 Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs