Trial record 1 of 1 for:
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
This study has been completed.
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Christopher Van Dyck, Yale University
ClinicalTrials.gov Identifier:
NCT00935493
First received: July 7, 2009
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cognitive Aging |
Drug: Guanfacine Drug: Placebo |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 154 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Guanfacine 0.1 mg po qhs |
Drug: Guanfacine
Guanfacine 0.1 mg po qhs
|
| Experimental: Guanfacine 0.5 mg po qhs |
Drug: Guanfacine
Guanfacine 0.5 mg po qhs
|
| Placebo Comparator: Placebo po qhs |
Drug: Placebo
Placebo po qhs
|
Detailed Description:
Primary:
- 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.
Secondary:
- 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.
Eligibility| Ages Eligible for Study: | 75 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935493
Locations
| United States, Connecticut | |
| Alzheimer's Disease Research Unit, Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06510 | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Christopher H van Dyck, MD | Yale University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Christopher Van Dyck, Principal Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT00935493 History of Changes |
| Other Study ID Numbers: | 0805003881, R01-030457-1 |
| Study First Received: | July 7, 2009 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by Yale University:
|
guanfacine aging cognitive aging |
prefrontal cognitive function executive function prefrontal cortex |
Additional relevant MeSH terms:
|
Delirium, Dementia, Amnestic, Cognitive Disorders Guanfacine Cognition Disorders Mental Disorders Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013