Trial record 1 of 1 for:    NCT00935493
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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):
Christopher Van Dyck, Yale University
ClinicalTrials.gov Identifier:
NCT00935493
First received: July 7, 2009
Last updated: November 6, 2012
Last verified: November 2012
  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:
  • Change in the Prefrontal Executive Function z-score between Baseline and Week 12 endpoint (mean z-score from Neuropsychological Test Battery) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADCS-CGIC [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life (SF-36 MCS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Frequency of Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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
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: Christopher Van Dyck, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00935493     History of Changes
Other Study ID Numbers: 0805003881, R01-030457-1
Study First Received: July 7, 2009
Last Updated: November 6, 2012
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:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Guanfacine
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 April 15, 2014