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

July 7, 2009
August 10, 2014
June 2009
August 2012   (final data collection date for primary outcome measure)
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

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 ]
Complete list of historical versions of study NCT00935493 on ClinicalTrials.gov Archive Site
  • 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.

  • 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 ]
Not Provided
Not Provided
 
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cognitive Aging
  • Drug: Guanfacine
    Guanfacine 0.1 mg po qhs
  • Drug: Guanfacine
    Guanfacine 0.5 mg po qhs
  • Drug: Placebo
    Placebo po qhs
  • Experimental: Guanfacine 0.1 mg po qhs
    Intervention: Drug: Guanfacine
  • Experimental: Guanfacine 0.5 mg po qhs
    Intervention: Drug: Guanfacine
  • Placebo Comparator: Placebo po qhs
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
154
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
75 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00935493
0805003881, R01-030457-1
Yes
Yale University
Yale University
National Institute on Aging (NIA)
Principal Investigator: Christopher H van Dyck, MD Yale University
Yale University
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP