Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2011

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.

Intervention(s) in this Clinical Trial

• Drug: Guanfacine
  • Guanfacine 0.1 mg po qhs
• Drug: Guanfacine
  • Guanfacine 0.5 mg po qhs
• Drug: Placebo
  • Placebo po qhs

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Guanfacine 0.1 mg po qhs
• Experimental: Guanfacine 0.5 mg po qhs
• Placebo Comparator: Placebo po qhs

Primary 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
    Safety Issue?: No

Secondary Measures

• ADCS-CGIC
  • Time Frame: 12 weeks
    Safety Issue?: No
• Quality of Life (SF-36 MCS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Frequency of Adverse Events
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 75 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Christopher H van Dyck, MD Principal Investigator Yale University  

Overall Contact: Nicole Barcelos, MS 203-764-8145 nicole.barcelos@yale.edu

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00935493

Study ID Number: 0805003881

ClinicalTrials.gov Identifier: NCT00935493

Health Authority: United States: Institutional Review Board

Yale ADRU Website