Trial record 1 of 1 for:    NCT00935493
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Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00935493
First received: July 7, 2009
Last updated: August 10, 2014
Last verified: August 2014
Results First Received: June 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cognitive Aging
Interventions: Drug: Guanfacine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
154 subjects were screened, of which 135 were eligible. Of the 135 eligible, 12 withdrew consent and therefore 123 were randomized.

Reporting Groups
  Description
Guanfacine 0.1 mg po Qhs Guanfacine: Guanfacine 0.1 mg po qhs
Guanfacine 0.5 mg po Qhs Guanfacine: Guanfacine 0.5 mg po qhs
Placebo po Qhs Placebo: Placebo po qhs

Participant Flow:   Overall Study
    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  
Lost to Follow-up                 1                 1                 1  
Treatment Discontinued                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline population consists of the 123 participants (out of 154) that met eligibility requirements and consented to participate in the study.

Reporting Groups
  Description
Guanfacine 0.1 mg po Qhs Guanfacine: Guanfacine 0.1 mg po qhs
Guanfacine 0.5 mg po Qhs Guanfacine: Guanfacine 0.5 mg po qhs
Placebo po Qhs Placebo: Placebo po qhs
Total Total of all reporting groups

Baseline Measures
    Guanfacine 0.1 mg po Qhs     Guanfacine 0.5 mg po Qhs     Placebo po Qhs     Total  
Number of Participants  
[units: participants]
  41     41     41     123  
Age  
[units: years]
Mean ± Standard Deviation
  80.0  ± 4.0     80.1  ± 4.0     80.5  ± 4.0     80.2  ± 4.0  
Gender  
[units: participants]
       
Female     19     18     17     54  
Male     22     23     24     69  



  Outcome Measures
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1.  Primary:   Mean in the Prefrontal Executive Function Z-score (PEF6_6)   [ Time Frame: 12 weeks ]

2.  Secondary:   Alzheimer’s Disease Cooperative Study—Clinical Global Impression of Change (ADCS-CGIC)   [ Time Frame: 12 weeks ]

3.  Secondary:   Quality of Life (SF-36 MCS)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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
e-mail: christopher.vandyck@yale.edu


No publications provided


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00935493     History of Changes
Other Study ID Numbers: 0805003881, R01-030457-1
Study First Received: July 7, 2009
Results First Received: June 18, 2014
Last Updated: August 10, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government