Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
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|ClinicalTrials.gov Identifier: NCT00935493|
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : August 11, 2014
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Aging||Drug: Guanfacine Drug: Placebo||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
|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
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|