Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

NCT00935493 | Completed Results DMC

• 2 other identifiers: 0805003881R01-030457-1
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Aging

Keywords

guanfacine; aging; cognitive aging; prefrontal cognitive function; executive function; prefrontal cortex

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)

  12 weeks

• Quality of Life (SF-36 MCS)

  12 weeks

Study Arms (3)

Guanfacine 0.1 mg po qhs

EXPERIMENTAL

Drug: Guanfacine

Guanfacine 0.5 mg po qhs

EXPERIMENTAL

Drug: Guanfacine

Placebo po qhs

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Guanfacine DRUG

Guanfacine 0.1 mg po qhs

Guanfacine 0.1 mg po qhs

Placebo DRUG

Placebo po qhs

Placebo po qhs

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Alzheimer's Disease Research Unit, Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Links

• Yale ADRU Website

MeSH Terms

Interventions

Guanfacine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Christopher van Dyck
• Organization: Yale University

christopher.vandyck@yale.edu

203-764-8100

Study Officials

• Christopher H van Dyck, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 13, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-08

Locations

US (1)