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Acetylcholinesterase Inhibitors to Improve Cognitive Function and Overall Rehabilitation After a Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227994
First Posted: September 28, 2005
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Eric Lenze, University of Pittsburgh
Results First Submitted: May 2, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cerebrovascular Accident
Interventions: Drug: Galantamine
Drug: Donepezil

  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
40 participants received study medication

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Galantamine

Galantamine for 12 weeks

Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.

Donepezil

Donepezil for 12 weeks

Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.


Participant Flow:   Overall Study
    Galantamine   Donepezil
STARTED   20   20 
COMPLETED   13   13 
NOT COMPLETED   7   7 



  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.
No text entered.

Reporting Groups
  Description
Galantamine

Galantamine for 12 weeks

Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.

Donepezil

Donepezil for 12 weeks

Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks.

Total Total of all reporting groups

Baseline Measures
   Galantamine   Donepezil   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   13   26 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      13 100.0%      13 100.0%      26 100.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.9  (7.5)   69.1  (6.4)   69.5  (7.0) 
Gender 
[Units: Participants]
Count of Participants
     
Female      3  23.1%      5  38.5%      8  30.8% 
Male      10  76.9%      8  61.5%      18  69.2% 
Region of Enrollment 
[Units: Participants]
     
United States   13   13   26 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Physical Function (Measured by the FIM-motor)   [ Time Frame: Measured at weeks 0 and 12 ]

2.  Secondary:   Medication Tolerability   [ Time Frame: Measured throughout the study ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eric Lenze
Organization: Washington University School of Medicine
phone: 314-362-1671
e-mail: lenzee@wustl.edu


Publications of Results:

Responsible Party: Eric Lenze, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00227994     History of Changes
Other Study ID Numbers: K23MH064196-01 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2005
First Posted: September 28, 2005
Results First Submitted: May 2, 2016
Results First Posted: December 28, 2016
Last Update Posted: December 28, 2016