CDP-Choline and Working Memory After TBI: A Neuroimaging Study
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|ClinicalTrials.gov Identifier: NCT00727246|
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : July 28, 2017
Last Update Posted : July 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries||Drug: CDP-Choline Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CDP-Choline and Working Memory After TBI: A Neuroimaging Study.|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Treatment with CDP-Choline
1000 mg CDP-Choline 2 x per day for 6 weeks.
Placebo Comparator: Placebo
Treatment with Placebo
Treatment with placebo for 6 weeks
- Cognitive Composite Score for Group of Subjects With TBI and Healthy Controls Matched by Age, Education, and Treatment Group. [ Time Frame: 6 weeks ].A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. A higher T-score indicates a higher level of cognitive function. Due to matching criteria of age range, gender and education level, as well as the small number of subjects with TBI who complete the study (n = 5), matched groups required a reduction to 2 subjects per group for analysis as planned per protocol. Due to the small number of subjects in this study overall, although analyses were run, results should be considered with caution.
- Cognitive Composite Score for Group of Subjects With TBI and Unmatched Healthy Controls [ Time Frame: 6 weeks ]A mean index score created as a composite cognitive performance across domains. Purpose was to serve as a measure of overall cognitive functioning for data analysis. Higher T-scores indicate higher levels of cognitive functioning. Due to the small number of subjects in this study, this second analysis was completed using the same number of subjects in the TBI and control groups, but without matching so that a slightly larger number of subject's data could be utilized. Although analyses were run, due to the very small number of participants in this study, results should be considered with caution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00727246
|United States, Pennsylvania|
|University of Pittsburgh, Department of Physical Medicine & Rehabilitation|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Patricia M. Arenth, Ph.D.||University of Pittsburgh|