Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects|
- 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
- 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.
|Study Start Date:||June 2009|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: Guanfacine 0.1 mg po qhs||
Guanfacine 0.1 mg po qhs
|Experimental: Guanfacine 0.5 mg po qhs||
Guanfacine 0.5 mg po qhs
|Placebo Comparator: Placebo po qhs||
Placebo po qhs
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935493
|United States, Connecticut|
|Alzheimer's Disease Research Unit, Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Christopher H van Dyck, MD||Yale University|