Cognitive AgingNCT00935493

Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

A study testing Guanfacine in people with Cognitive Aging, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 75 years and olderHealthy volunteers can take part
Conditions the study is for: Cognitive Aging
What is being tested?: Guanfacine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Aug 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 75 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Alzheimer's Disease Research Unit, Yale University School of Medicine
New Haven, Connecticut, 06510

Other trials in United States

About this study

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.

Read the 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.

Conditions: Cognitive Aging
Being tested: Guanfacine, Placebo
Keywords: guanfacine, aging, cognitive aging, prefrontal cognitive function, executive function, prefrontal cortex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GuanfacineDrug
Guanfacine 0.1 mg po qhs
GuanfacineDrug
Guanfacine 0.5 mg po qhs
PlaceboDrug
Placebo po qhs

Study groups in NCT00935493
Study group	Role	What they receive
Guanfacine 0.1 mg po qhs	Experimental	Not described Receives: Drug: Guanfacine
Guanfacine 0.5 mg po qhs	Experimental	Not described Receives: Drug: Guanfacine
Placebo po qhs	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 weeks

Secondary outcomes (2)

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.
Measured: 12 weeks
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Aug 2012

First posted9 Jul 2009 (estimated)
Study startJun 2009
Primary completionAug 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cognitive AgingStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00935493
Sponsor's protocol ID: 0805003881
Other IDs: R01-030457-1
Status last verified: Aug 2014
First submitted: 7 Jul 2009
Last updated: 13 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty

All Cognitive Aging trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
ClinicalTrials.gov ID: NCT00935493
Acronym / sponsor ID: 0805003881
Conditions: Cognitive Aging
Keywords: guanfacine, aging, cognitive aging, prefrontal cognitive function, executive function, prefrontal cortex
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Jun 2009
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 9 Jul 2009 (estimated)
Results: Posted 11 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 75 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GuanfacineGuanfacine 0.1 mg po qhs	Drug	Guanfacine 0.1 mg po qhs
GuanfacineGuanfacine 0.5 mg po qhs	Drug	Guanfacine 0.5 mg po qhs
PlaceboPlacebo po qhs	Drug	Placebo po qhs

Primary outcome

Mean in the Prefrontal Executive Function Z-score (PEF6_6)
Time frame: 12 weeks
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

2 secondary outcomes

Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)
Time frame: 12 weeks
Quality of Life (SF-36 MCS)
Time frame: 12 weeks

Results and safety

Results posted to the registry on 11 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guanfacine 0.1 mg po Qhs	41	40
Guanfacine 0.5 mg po Qhs	41	39
Placebo po Qhs	41	40

Primary outcome: Mean in the Prefrontal Executive Function Z-score (PEF6_6)

Time frame: 12 weeks. Least squares mean (Standard Error). Unit: Z-score

Measure	Guanfacine 0.1 mg n = 40	Guanfacine 0.5 mg n = 39	Placebo n = 40
Value	0.121 (0.056)	0.213 (0.056)	0.270 (0.056)

Guanfacine 0.1 mg vs Placebo: p = 0.06, Regression, Linear
Guanfacine 0.5 mg vs Placebo: p = 0.47, Regression, Linear

Population analysed: 119 of the 123 trial participants had outcome data recorded at 12 weeks follow-up.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guanfacine 0.1 mg	2 of 41 (4.9%)	25 of 41 (61%)	Not reported
Guanfacine 0.5 mg	1 of 41 (2.4%)	32 of 41 (78%)	Not reported
Placebo	2 of 41 (4.9%)	34 of 41 (82.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Yale ADRU WebsiteLink provided by the sponsor.

Related trials for Cognitive Aging

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Obesity
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Active, not recruiting
Multimodal Training With Immersive Virtual Reality to Improve the Cognitive Health and Emotional Well-being of Older Women Living Alone
Social Isolation in Older Adults, Poverty

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher H van Dyck, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Guanfacine in people with Cognitive Aging, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean in the Prefrontal Executive Function Z-score (PEF6_6) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00935493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.