This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    NCT00935493
Previous Study | Return to List | Next Study

Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects

This study has been completed.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
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;   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
  Hide 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
  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
  Hide 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
  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 
Overall Participants Analyzed 
[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
  Show All 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
  Hide 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
  Hide 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
R01-030457-1
Study First Received: July 7, 2009
Results First Received: June 18, 2014
Last Updated: August 10, 2014