Trial record 1 of 1 for: Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

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Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

This study has been completed.

Sponsor:

Collaborator:

National Institute on Aging (NIA)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2009

Last Updated Date

November 6, 2012

Start Date ^ICMJE

June 2009

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00935493 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

Official Title ^ICMJE

Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cognitive Aging

Intervention ^ICMJE

Drug: Guanfacine
Guanfacine 0.1 mg po qhs
Drug: Guanfacine
Guanfacine 0.5 mg po qhs
Drug: Placebo
Placebo po qhs

Study Arm (s)

Experimental: Guanfacine 0.1 mg po qhs
Intervention: Drug: Guanfacine
Experimental: Guanfacine 0.5 mg po qhs
Intervention: Drug: Guanfacine
Placebo Comparator: Placebo po qhs
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

154

Completion Date

August 2012

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

75 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00935493

Other Study ID Numbers ^ICMJE

0805003881, R01-030457-1

Has Data Monitoring Committee

Yes

Responsible Party

Christopher Van Dyck, Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Institute on Aging (NIA)

Investigators ^ICMJE

Principal Investigator:

Christopher H van Dyck, MD

Yale University

Information Provided By

Yale University

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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