Skip to main content
OpenTrials
Completed

NCT Number: NCT00935493

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Aging

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guanfacine

Drug

Guanfacine 0.1 mg po qhs

Placebo

Drug

Placebo po qhs

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 9, 2009
Registry last updated
Aug 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.