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Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

Primary Purpose

Cognitive Aging

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guanfacine
Guanfacine
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Aging focused on measuring guanfacine, aging, cognitive aging, prefrontal cognitive function, executive function, prefrontal cortex

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alzheimer's Disease Research Unit, Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Guanfacine 0.1 mg po qhs

Guanfacine 0.5 mg po qhs

Placebo po qhs

Arm Description

Outcomes

Primary Outcome Measures

Mean in the Prefrontal Executive Function Z-score (PEF6_6)
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)
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)
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.

Full Information

First Posted
July 7, 2009
Last Updated
August 10, 2014
Sponsor
Yale University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00935493
Brief Title
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Official Title
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Aging
Keywords
guanfacine, aging, cognitive aging, prefrontal cognitive function, executive function, prefrontal cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine 0.1 mg po qhs
Arm Type
Experimental
Arm Title
Guanfacine 0.5 mg po qhs
Arm Type
Experimental
Arm Title
Placebo po qhs
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Guanfacine
Intervention Description
Guanfacine 0.1 mg po qhs
Intervention Type
Drug
Intervention Name(s)
Guanfacine
Intervention Description
Guanfacine 0.5 mg po qhs
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo po qhs
Primary Outcome Measure Information:
Title
Mean in the Prefrontal Executive Function Z-score (PEF6_6)
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Description
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.
Time Frame
12 weeks
Title
Quality of Life (SF-36 MCS)
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher H van Dyck, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzheimer's Disease Research Unit, Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Links:
URL
http://alzheimers.yale.edu
Description
Yale ADRU Website

Learn more about this trial

Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

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