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 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|
- 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 ]
- 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 ]
|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.
|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|