N/A
N=123
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Cognitive Aging
Bottom Line
View on ClinicalTrials.gov: NCT00935493 ↗Enrolled (actual)
123
Serious AEs
4.1%
Results posted
Aug 2014
Primary outcome: Primary: Mean in the Prefrontal Executive Function Z-score (PEF6_6) — 0.121; 0.213; 0.270 Z-score — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Guanfacine (Drug); Placebo (Drug)
- Age
- Older Adult · 75+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean in the Prefrontal Executive Function Z-score (PEF6_6) |
0.121; 0.213; 0.270 | 0.06 |
| SECONDARY Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) |
4; 2; 3; 20; 22; 25 | 0.67 |
| SECONDARY Quality of Life (SF-36 MCS) |
-0.618; -0.960; -0.083 | 0.65 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00935493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.