Cognitive Aging Clinical Trial
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Alzheimer's Disease Research Unit, Yale University School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute on Aging (NIA) |
United States,
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 |
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