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Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

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ClinicalTrials.gov Identifier: NCT00935493
Recruitment Status : Completed
First Posted : July 9, 2009
Results First Posted : August 11, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cognitive Aging
Interventions Drug: Guanfacine
Drug: Placebo
Enrollment 154
Recruitment Details  
Pre-assignment Details 154 subjects were screened, of which 135 were eligible. Of the 135 eligible, 12 withdrew consent and therefore 123 were randomized.
Arm/Group Title Guanfacine 0.1 mg po Qhs Guanfacine 0.5 mg po Qhs Placebo po Qhs
Hide Arm/Group Description Guanfacine: Guanfacine 0.1 mg po qhs Guanfacine: Guanfacine 0.5 mg po qhs Placebo: Placebo po qhs
Period Title: Overall Study
Started 41 41 41
Completed 40 39 40
Not Completed 1 2 1
Reason Not Completed
Lost to Follow-up             1             1             1
Treatment Discontinued             0             1             0
Arm/Group Title Guanfacine 0.1 mg po Qhs Guanfacine 0.5 mg po Qhs Placebo po Qhs Total
Hide Arm/Group Description Guanfacine: Guanfacine 0.1 mg po qhs Guanfacine: Guanfacine 0.5 mg po qhs Placebo: Placebo po qhs Total of all reporting groups
Overall Number of Baseline Participants 41 41 41 123
Hide Baseline Analysis Population Description
The baseline population consists of the 123 participants (out of 154) that met eligibility requirements and consented to participate in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 41 participants 41 participants 123 participants
80.0  (4.0) 80.1  (4.0) 80.5  (4.0) 80.2  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 41 participants 123 participants
Female
19
  46.3%
18
  43.9%
17
  41.5%
54
  43.9%
Male
22
  53.7%
23
  56.1%
24
  58.5%
69
  56.1%
1.Primary Outcome
Title Mean in the Prefrontal Executive Function Z-score (PEF6_6)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
119 of the 123 trial participants had outcome data recorded at 12 weeks follow-up.
Arm/Group Title Guanfacine 0.1 mg Guanfacine 0.5 mg Placebo
Hide Arm/Group Description:
Guanfacine: Guanfacine 0.1 mg
Guanfacine: Guanfacine 0.5 mg
Placebo: Placebo
Overall Number of Participants Analyzed 40 39 40
Least Squares Mean (Standard Error)
Unit of Measure: Z-score
0.121  (0.056) 0.213  (0.056) 0.270  (0.056)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guanfacine 0.1 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guanfacine 0.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Secondary Outcome
Title Alzheimer’s Disease Cooperative Study—Clinical Global Impression of Change (ADCS-CGIC)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
119 of the 123 trial participants had outcome data recorded at 12 weeks of follow-up
Arm/Group Title Guanfacine 0.1 mg Guanfacine 0.5 mg Placebo
Hide Arm/Group Description:
Guanfacine: Guanfacine 0.1 mg
Guanfacine: Guanfacine 0.5 mg
Placebo: Placebo
Overall Number of Participants Analyzed 40 39 40
Measure Type: Number
Unit of Measure: participants
Worse 4 2 3
No Change 20 22 25
Improved 16 15 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guanfacine 0.1 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guanfacine 0.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Quality of Life (SF-36 MCS)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
119 of the 123 trial participants had outcome data recorded at 12 weeks of follow up
Arm/Group Title Guanfacine 0.1 mg Guanfacine 0.5 mg Placebo
Hide Arm/Group Description:
Guanfacine: Guanfacine 0.1 mg
Guanfacine: Guanfacine 0.5 mg
Placebo: Placebo
Overall Number of Participants Analyzed 40 39 40
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.618  (0.825) -0.960  (0.835) -0.083  (0.829)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guanfacine 0.1 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Guanfacine 0.5 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guanfacine 0.1 mg Guanfacine 0.5 mg Placebo
Hide Arm/Group Description Guanfacine: Guanfacine 0.1 mg Guanfacine: Guanfacine 0.5 mg Placebo: Placebo
All-Cause Mortality
Guanfacine 0.1 mg Guanfacine 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Guanfacine 0.1 mg Guanfacine 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/41 (4.88%)   1/41 (2.44%)   2/41 (4.88%) 
Blood and lymphatic system disorders       
Hyponatremia *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Cardiac disorders       
Non-ST Elevation Myocardial Infarction *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Infections and infestations       
Pneumonia *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Nervous system disorders       
Speech impairment/Use of right side *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Right Frontal Subarachnoid Hemorrhage *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Guanfacine 0.1 mg Guanfacine 0.5 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/41 (60.98%)   32/41 (78.05%)   34/41 (82.93%) 
Blood and lymphatic system disorders       
Hyponatremia *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Cardiac disorders       
Atrial Fibrillation   1/41 (2.44%)  1/41 (2.44%)  0/41 (0.00%) 
Chest Pain *  0/41 (0.00%)  1/41 (2.44%)  1/41 (2.44%) 
Hypertension *  1/41 (2.44%)  2/41 (4.88%)  0/41 (0.00%) 
Myocardial Infarction *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Palpitations *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Tachycardia *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Ear and labyrinth disorders       
Otitis Media *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Tinnitus *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Eye disorders       
Cataracts   2/41 (4.88%)  0/41 (0.00%)  0/41 (0.00%) 
Conjunctivitis   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Sty   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Subconjunctival Hemorrhage   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Worsening in Near Vision   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Gastrointestinal disorders       
Abdominal Cramps *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Abdominal Pain *  0/41 (0.00%)  1/41 (2.44%)  1/41 (2.44%) 
Anorexia *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Constipation *  3/41 (7.32%)  0/41 (0.00%)  1/41 (2.44%) 
Diarrhea   2/41 (4.88%)  2/41 (4.88%)  0/41 (0.00%) 
Difficulty Swallowing   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Diverticulitis   0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Flatulence   0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Gastroenteritis   0/41 (0.00%)  0/41 (0.00%)  4/41 (9.76%) 
Hemorrhoids   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Inguinal Hernia   0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Irregular Bowl Movements   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Nausea   2/41 (4.88%)  1/41 (2.44%)  1/41 (2.44%) 
General disorders       
Cold Sores *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Dental Implants *  0/41 (0.00%)  1/41 (2.44%)  1/41 (2.44%) 
Dry Mouth *  3/41 (7.32%)  7/41 (17.07%)  0/41 (0.00%) 
Dry Socket *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Epistaxis *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Rhinorrhea *  1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Sinus Congestion *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Sinusitis *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Sleep Apnea *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Sneezing *  0/41 (0.00%)  2/41 (4.88%)  0/41 (0.00%) 
Sore Throat *  1/41 (2.44%)  1/41 (2.44%)  0/41 (0.00%) 
Throat Swelling *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Tooth Abscess *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Allergies   0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Diaphoresis   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Fall   2/41 (4.88%)  3/41 (7.32%)  1/41 (2.44%) 
Fever   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Night Sweats   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Infections and infestations       
Infection Post Tooth Extraction *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Musculoskeletal and connective tissue disorders       
Fracture   1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Joint Pain   1/41 (2.44%)  4/41 (9.76%)  1/41 (2.44%) 
Leg Cramps   0/41 (0.00%)  0/41 (0.00%)  2/41 (4.88%) 
Leg Pain   0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Muscle Spasm   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Muscle Strain   0/41 (0.00%)  1/41 (2.44%)  1/41 (2.44%) 
Muscle Weakness   0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Neck pain   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Osteoarthritis   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Sciatica   1/41 (2.44%)  1/41 (2.44%)  2/41 (4.88%) 
Tendonitis   1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Low Back Pain   0/41 (0.00%)  0/41 (0.00%)  3/41 (7.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Precancerous Lesion On Tongue *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Nervous system disorders       
Cognitive Worsening   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Fatigue   3/41 (7.32%)  7/41 (17.07%)  3/41 (7.32%) 
Headache   2/41 (4.88%)  2/41 (4.88%)  1/41 (2.44%) 
Insomnia   1/41 (2.44%)  2/41 (4.88%)  1/41 (2.44%) 
Ischemic Stroke   2/41 (4.88%)  0/41 (0.00%)  0/41 (0.00%) 
Lightheadedness   0/41 (0.00%)  4/41 (9.76%)  4/41 (9.76%) 
Sedation   3/41 (7.32%)  1/41 (2.44%)  1/41 (2.44%) 
Subarachnoid Hemorrhage   0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Syncope   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Vertigo   1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Psychiatric disorders       
Anxiety   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Irritability   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Sadness   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Renal and urinary disorders       
Difficuluty Urinating   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Hematuria   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Urinary Frequency   0/41 (0.00%)  2/41 (4.88%)  0/41 (0.00%) 
Urinary Tract Infection   1/41 (2.44%)  1/41 (2.44%)  3/41 (7.32%) 
Reproductive system and breast disorders       
Diminished Libido   1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Uterine Polyp   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchitis   0/41 (0.00%)  2/41 (4.88%)  0/41 (0.00%) 
Cough   2/41 (4.88%)  1/41 (2.44%)  2/41 (4.88%) 
Shortness of Breath   0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Upper Respiratory Infection   4/41 (9.76%)  3/41 (7.32%)  9/41 (21.95%) 
Skin and subcutaneous tissue disorders       
Abrasion *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Actinic Keratosis *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Bee Stings *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Blister *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Bruising *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Hair Loss *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Insect Bite *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Laceration *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Poison Ivy *  1/41 (2.44%)  0/41 (0.00%)  0/41 (0.00%) 
Pruritus *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Rash *  1/41 (2.44%)  0/41 (0.00%)  1/41 (2.44%) 
Shingles *  0/41 (0.00%)  0/41 (0.00%)  1/41 (2.44%) 
Varicose Veins *  0/41 (0.00%)  1/41 (2.44%)  0/41 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Christopher van Dyck
Organization: Yale University
Phone: 203-764-8100
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00935493     History of Changes
Other Study ID Numbers: 0805003881
R01-030457-1
First Submitted: July 7, 2009
First Posted: July 9, 2009
Results First Submitted: June 18, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 13, 2014