Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

Cognitive Aging Clinical Trial

Official title:

Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935493
• Other study ID #: 0805003881
• Secondary ID: R01-030457-1
• Status: Completed
• Phase: N/A
• First received: July 7, 2009
• Last updated: August 10, 2014
• Start date: June 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Aging

Intervention

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

Locations

Country	Name	City	State
United States	Alzheimer's Disease Research Unit, Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks	No
Secondary	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.	12 weeks	No
Secondary	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.	12 weeks	No

External Links

•   Yale ADRU Website