Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
NCT00935493, Not applicable, Completed, Yale University; results first posted 2014-08-11
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects | ClinicalTrials.gov |
| NCT number | NCT00935493 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 154 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Yale University | ClinicalTrials.gov |
| Conditions | Cognitive Aging | ClinicalTrials.gov |
| Interventions | Guanfacine, Guanfacine, Placebo | ClinicalTrials.gov |
| First posted | 2009-07-09 | ClinicalTrials.gov |
| Last updated | 2014-08-13 | ClinicalTrials.gov |
| Results first posted | 2014-08-11 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean in the Prefrontal Executive Function Z-score (PEF6_6) | 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 | ClinicalTrials.gov |
| Secondary | Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | 12 weeks | 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. | ClinicalTrials.gov |
| Secondary | Quality of Life (SF-36 MCS) | 12 weeks | 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. | ClinicalTrials.gov |
Outcomes 3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Mean in the Prefrontal Executive Function Z-score (PEF6_6) | 12 weeks | 119 of the 123 trial participants had outcome data recorded at 12 weeks follow-up. | Z-score | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
| SECONDARY | Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | 12 weeks | 119 of the 123 trial participants had outcome data recorded at 12 weeks of follow-up | participants | NUMBER | ClinicalTrials.gov |
| SECONDARY | Quality of Life (SF-36 MCS) | 12 weeks | 119 of the 123 trial participants had outcome data recorded at 12 weeks of follow up | units on a scale | LEAST_SQUARES_MEAN | ClinicalTrials.gov |
Results by group 15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Mean in the Prefrontal Executive Function Z-score (PEF6_6) | Guanfacine 0.1 mg | 0.121 | Standard Error 0.056 | Z-score | ClinicalTrials.gov | |
| Mean in the Prefrontal Executive Function Z-score (PEF6_6) | Guanfacine 0.5 mg | 0.213 | Standard Error 0.056 | Z-score | ClinicalTrials.gov | |
| Mean in the Prefrontal Executive Function Z-score (PEF6_6) | Placebo | 0.270 | Standard Error 0.056 | Z-score | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Guanfacine 0.1 mg | Worse | 4 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Guanfacine 0.5 mg | Worse | 2 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Placebo | Worse | 3 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Guanfacine 0.1 mg | No Change | 20 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Guanfacine 0.5 mg | No Change | 22 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Placebo | No Change | 25 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Guanfacine 0.1 mg | Improved | 16 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Guanfacine 0.5 mg | Improved | 15 | participants | ClinicalTrials.gov | |
| Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) | Placebo | Improved | 12 | participants | ClinicalTrials.gov | |
| Quality of Life (SF-36 MCS) | Guanfacine 0.1 mg | -0.618 | Standard Error 0.825 | units on a scale | ClinicalTrials.gov | |
| Quality of Life (SF-36 MCS) | Guanfacine 0.5 mg | -0.960 | Standard Error 0.835 | units on a scale | ClinicalTrials.gov | |
| Quality of Life (SF-36 MCS) | Placebo | -0.083 | Standard Error 0.829 | units on a scale | ClinicalTrials.gov |
Participant flow 9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Guanfacine 0.1 mg po Qhs | 41 | ClinicalTrials.gov | |
| Overall Study | STARTED | Guanfacine 0.5 mg po Qhs | 41 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo po Qhs | 41 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Guanfacine 0.1 mg po Qhs | 40 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Guanfacine 0.5 mg po Qhs | 39 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo po Qhs | 40 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Guanfacine 0.1 mg po Qhs | 1 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Guanfacine 0.5 mg po Qhs | 2 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo po Qhs | 1 | ClinicalTrials.gov |
Adverse events 300
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Atrial Fibrillation | Cardiac disorders | Guanfacine 0.1 mg | 1 | 41 | ClinicalTrials.gov | |
| other | Atrial Fibrillation | Cardiac disorders | Guanfacine 0.5 mg | 1 | 41 | ClinicalTrials.gov | |
| other | Atrial Fibrillation | Cardiac disorders | Placebo | 0 | 41 | ClinicalTrials.gov | |
| other | Chest Pain | Cardiac disorders | Guanfacine 0.1 mg | 0 | 41 | ClinicalTrials.gov | |
| other | Chest Pain | Cardiac disorders | Guanfacine 0.5 mg | 1 | 41 | ClinicalTrials.gov | |
| other | Chest Pain | Cardiac disorders | Placebo | 1 | 41 | ClinicalTrials.gov | |
| other | Hypertension | Cardiac disorders | Guanfacine 0.1 mg | 1 | 41 | ClinicalTrials.gov | |
| other | Hypertension | Cardiac disorders | Guanfacine 0.5 mg | 2 | 41 | ClinicalTrials.gov | |
| other | Hypertension | Cardiac disorders | Placebo | 0 | 41 | ClinicalTrials.gov | |
| other | Myocardial Infarction | Cardiac disorders | Guanfacine 0.1 mg | 0 | 41 | ClinicalTrials.gov | |
| other | Myocardial Infarction | Cardiac disorders | Guanfacine 0.5 mg | 0 | 41 | ClinicalTrials.gov | |
| other | Myocardial Infarction | Cardiac disorders | Placebo | 1 | 41 | ClinicalTrials.gov | |
| other | Palpitations | Cardiac disorders | Guanfacine 0.1 mg | 1 | 41 | ClinicalTrials.gov | |
| other | Palpitations | Cardiac disorders | Guanfacine 0.5 mg | 0 | 41 | ClinicalTrials.gov | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 41 | ClinicalTrials.gov | |
| other | Tachycardia | Cardiac disorders | Guanfacine 0.1 mg | 0 | 41 | ClinicalTrials.gov | |
| other | Tachycardia | Cardiac disorders | Guanfacine 0.5 mg | 1 | 41 | ClinicalTrials.gov | |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 41 | ClinicalTrials.gov | |
| other | Abrasion | Skin and subcutaneous tissue disorders | Guanfacine 0.1 mg | 0 | 41 | ClinicalTrials.gov | |
| other | Abrasion | Skin and subcutaneous tissue disorders | Guanfacine 0.5 mg | 0 | 41 | ClinicalTrials.gov |
Adverse event totals 9
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Guanfacine 0.1 mg | ClinicalTrials.gov | ||
| Total, all-cause mortality | Guanfacine 0.5 mg | ClinicalTrials.gov | ||
| Total, all-cause mortality | Placebo | ClinicalTrials.gov | ||
| Total, other adverse events | Guanfacine 0.1 mg | 25 | 41 | ClinicalTrials.gov |
| Total, other adverse events | Guanfacine 0.5 mg | 32 | 41 | ClinicalTrials.gov |
| Total, other adverse events | Placebo | 34 | 41 | ClinicalTrials.gov |
| Total, serious adverse events | Guanfacine 0.1 mg | 2 | 41 | ClinicalTrials.gov |
| Total, serious adverse events | Guanfacine 0.5 mg | 1 | 41 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo | 2 | 41 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 5
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Paired Associate Learning | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Tower Planning | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)