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Trial record 1 of 1 for:    NCT00935493
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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
Information provided by (Responsible Party):

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

  Participant Flow

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 41   41   41   123 
[Units: Years]
Mean (Standard Deviation)
 80.0  (4.0)   80.1  (4.0)   80.5  (4.0)   80.2  (4.0) 
[Units: Participants]
Female   19   18   17   54 
Male   22   23   24   69 

  Outcome Measures

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

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

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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00935493     History of Changes
Other Study ID Numbers: 0805003881
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