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Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369785
First Posted: August 29, 2006
Last Update Posted: June 20, 2017
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 Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
Results First Submitted: July 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions: Brain Tumors
Metastatic Disease
Interventions: Drug: donepezil hydrochloride
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
Patients were accrued between 2/2008 and 12/2011 at NCI CCOP sites across the nation.

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
Arm I - Donepezil

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

Arm II - Control

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day

Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day


Participant Flow:   Overall Study
    Arm I - Donepezil   Arm II - Control
STARTED   99   99 
COMPLETED   72   74 
NOT COMPLETED   27   25 
Physician Decision                3                2 
Death                1                2 
Withdrawal by Subject                7                6 
Toxicity                6                4 
Never started                0                2 
Progression                4                4 
Multiple reasons                6                5 



  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.
All randomized patients

Reporting Groups
  Description
Arm I - Donepezil

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

Arm II - Control

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day

Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

Total Total of all reporting groups

Baseline Measures
   Arm I - Donepezil   Arm II - Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 99   99   198 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      72  72.7%      83  83.8%      155  78.3% 
>=65 years      27  27.3%      16  16.2%      43  21.7% 
Age 
[Units: Years]
Median (Full Range)
 56.1 
 (19 to 84) 
 54.9 
 (19 to 81) 
 55.1 
 (19 to 84) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      56  56.6%      50  50.5%      106  53.5% 
Male      43  43.4%      49  49.5%      92  46.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   1.0%      0   0.0%      1   0.5% 
Not Hispanic or Latino      96  97.0%      97  98.0%      193  97.5% 
Unknown or Not Reported      2   2.0%      2   2.0%      4   2.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.0%      0   0.0%      1   0.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      7   7.1%      9   9.1%      16   8.1% 
White      91  91.9%      90  90.9%      181  91.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   99   99   198 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Memory as Quantified by HVLT-immediate Recall   [ Time Frame: 24 weeks ]

2.  Primary:   Memory as Quantified by the HVLT-discrimination   [ Time Frame: 24 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: Dr. Doug Case
Organization: Wake Forest NCORP Research Base
phone: (336) 716-1048
e-mail: dcase@wakehealth.edu



Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00369785     History of Changes
Other Study ID Numbers: REBACCCWFU 91105
U10CA081851 ( U.S. NIH Grant/Contract )
First Submitted: August 24, 2006
First Posted: August 29, 2006
Results First Submitted: July 15, 2015
Results First Posted: June 20, 2017
Last Update Posted: June 20, 2017