Trial record 1 of 1 for:    Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
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Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00935493
First received: July 7, 2009
Last updated: August 10, 2014
Last verified: August 2014
  Purpose

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 Intervention
Cognitive Aging
Drug: Guanfacine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Mean in the Prefrontal Executive Function Z-score (PEF6_6) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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:
  • Alzheimer's Disease Cooperative Study—Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Quality of Life (SF-36 MCS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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.



Enrollment: 154
Study Start Date: June 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935493

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

Additional Information:
No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00935493     History of Changes
Other Study ID Numbers: 0805003881, R01-030457-1
Study First Received: July 7, 2009
Results First Received: June 18, 2014
Last Updated: August 10, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Yale University:
guanfacine
aging
cognitive aging
prefrontal cognitive function
executive function
prefrontal cortex

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Guanfacine
Cognition Disorders
Mental Disorders
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014