An interventional study of Guanfacine and Guanfacine in Cognitive Aging, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-13.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
Primary:
Secondary:
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,099 are open to participants now.
This study's enrollment of 154 is above the median of 65 across 2,807 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects enrolled will be nondemented, male and female individuals who meet the following inclusion criteria:
Exclusion Criteria:
Drug: Guanfacine
Drug: Guanfacine
Drug: Placebo
Guanfacine 0.1 mg po qhs
Guanfacine 0.5 mg po qhs
Placebo po qhs
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
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 12 weeks
| Milestone | Guanfacine 0.1 mg po Qhs | Guanfacine 0.5 mg po Qhs | Placebo po Qhs |
|---|---|---|---|
| Started | 41 | 41 | 41 |
| Completed | 40 | 39 | 40 |
| Not completed | 1 | 2 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 |
| Withdrew: Treatment discontinued | 0 | 1 | 0 |
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
| Z-score | Guanfacine 0.1 mg | Guanfacine 0.5 mg | Placebo |
|---|---|---|---|
| Mean in the Prefrontal Executive Function Z-score (PEF6_6) | 0.121 ± 0.056 | 0.213 ± 0.056 | 0.270 ± 0.056 |
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.
| participants | Guanfacine 0.1 mg | Guanfacine 0.5 mg | Placebo |
|---|---|---|---|
| Worse | 4 | 2 | 3 |
| No Change | 20 | 22 | 25 |
| Improved | 16 | 15 | 12 |
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.
| units on a scale | Guanfacine 0.1 mg | Guanfacine 0.5 mg | Placebo |
|---|---|---|---|
| Quality of Life (SF-36 MCS) | -0.618 ± 0.825 | -0.960 ± 0.835 | -0.083 ± 0.829 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Guanfacine 0.1 mg | — | 2/41 (4.9%) | 25/41 (61%) |
| Guanfacine 0.5 mg | — | 1/41 (2.4%) | 32/41 (78%) |
| Placebo | — | 2/41 (4.9%) | 34/41 (82.9%) |
| Event | Guanfacine 0.1 mg | Guanfacine 0.5 mg | Placebo |
|---|---|---|---|
| Speech impairment/Use of right sideNervous system disorders | 1/41 | 0/41 | 0/41 |
| PneumoniaInfections and infestations | 1/41 | 0/41 | 0/41 |
| HyponatremiaBlood and lymphatic system disorders | 0/41 | 1/41 | 0/41 |
| Non-ST Elevation Myocardial InfarctionCardiac disorders | 0/41 | 0/41 | 1/41 |
| Right Frontal Subarachnoid HemorrhageNervous system disorders | 0/41 | 0/41 | 1/41 |
| Event | Guanfacine 0.1 mg | Guanfacine 0.5 mg | Placebo |
|---|---|---|---|
| Upper Respiratory InfectionRespiratory, thoracic and mediastinal disorders | 4/41 | 3/41 | 9/41 |
| Dry MouthGeneral disorders | 3/41 | 7/41 | 0/41 |
| FatigueNervous system disorders | 3/41 | 7/41 | 3/41 |
| GastroenteritisGastrointestinal disorders | 0/41 | 0/41 | 4/41 |
| Joint PainMusculoskeletal and connective tissue disorders | 1/41 | 4/41 | 1/41 |
| LightheadednessNervous system disorders | 0/41 | 4/41 | 4/41 |
| ConstipationGastrointestinal disorders | 3/41 | 0/41 | 1/41 |
| FallGeneral disorders | 2/41 | 3/41 | 1/41 |
| SedationNervous system disorders | 3/41 | 1/41 | 1/41 |
| Urinary Tract InfectionRenal and urinary disorders | 1/41 | 1/41 | 3/41 |
The baseline population consists of the 123 participants (out of 154) that met eligibility requirements and consented to participate in the study.
| Age, Continuous(years) | Guanfacine 0.1 mg po Qhs | Guanfacine 0.5 mg po Qhs | Placebo po Qhs | Total |
|---|---|---|---|---|
| Mean | 80.0 ± 4.0 | 80.1 ± 4.0 | 80.5 ± 4.0 | 80.2 ± 4.0 |
| Sex: Female, Male(Participants) | Guanfacine 0.1 mg po Qhs | Guanfacine 0.5 mg po Qhs | Placebo po Qhs | Total |
|---|---|---|---|---|
| Female | 19 | 18 | 17 | 54 |
| Male | 22 | 23 | 24 | 69 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Yale University