Trial Outcomes & Findings for CDP-Choline and Working Memory After TBI: A Neuroimaging Study (NCT NCT00727246)

Results Overview

.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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With TBI Who Received CDP-Choline Participants who have experienced a TBI and were randomly assigned to receive the study supplement	Participants With TBI Who Received Placebo Participants with a history of TBI who were randomly assigned to the placebo group	Control Participants Who Received CDP-Choline Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline	Control Participants Who Received Placebo Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
Overall Study STARTED	3	3	8	5
Overall Study COMPLETED	3	2	7	3
Overall Study NOT COMPLETED	0	1	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Participants With TBI Who Received Placebo Participants with a history of TBI who were randomly assigned to the placebo group	Control Participants Who Received CDP-Choline Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline	Control Participants Who Received Placebo Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
Overall Study could not complete MRI	1	0	1
Overall Study incidental finding	0	0	1
Overall Study withdrawn	0	1	0

Baseline Characteristics

CDP-Choline and Working Memory After TBI: A Neuroimaging Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With TBI Who Received CDP-Choline n=3 Participants Participants with TBI who were randomized to receive the CDP-Choline	Participants With TBI Who Received Placebo n=2 Participants Participants with TBI who were randomized to receive Placebo	Control Participants Who Received CDP-Choline n=7 Participants Participants without a history of TBI who were randomized to receive CDP-Choline	Control Participants Who Received Placebo n=3 Participants Participants without a history of TBI who were randomized to receive placebo	Total n=15 Participants Total of all reporting groups
Age, Continuous	30.66 years STANDARD_DEVIATION 12.42 • n=5 Participants	25 years STANDARD_DEVIATION 1.41 • n=7 Participants	29 years STANDARD_DEVIATION 7.90 • n=5 Participants	34 years STANDARD_DEVIATION 13 • n=4 Participants	29.8 years STANDARD_DEVIATION 8.98 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	3 participants n=4 Participants	15 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: A repeated measure ANOVA was completed to evaluate potential differences in cognitive composite scores of subjects with TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. Matching criteria and small n for TBI group reduced group sizes.

.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.

Outcome measures

Outcome measures
Measure	Participants With TBI Who Received CDP-Choline n=2 Participants Participants with TBI who were randomized to receive the CDP-Choline	Participants With TBI Who Received Placebo n=2 Participants Participants with TBI who were randomized to receive Placebo	Control Participants Who Received CDP-Choline n=2 Participants Participants without a history of TBI who were randomized to receive CDP-Choline	Control Participants Who Received Placebo n=2 Participants Participants without a history of TBI who were randomized to receive placebo
Cognitive Composite Score for Group of Subjects With TBI and Healthy Controls Matched by Age, Education, and Treatment Group.	42.750 T-score Interval 27.163 to 58.337	50.500 T-score Interval 34.913 to 66.087	49.500 T-score Interval 33.913 to 65.987	55.000 T-score Interval 39.413 to 70.587

PRIMARY outcome

Timeframe: 6 weeks

Population: cognitive composite scores of individuals with a history of TBI as compared to healthy controls 6 weeks after treatment with CDP Choline (1000 mg CDP-Choline 2 x per day for 6 weeks) as compared to those treated with placebo. See note above related to the limited number of subjects in each group.

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.

Outcome measures

Outcome measures
Measure	Participants With TBI Who Received CDP-Choline n=2 Participants Participants with TBI who were randomized to receive the CDP-Choline	Participants With TBI Who Received Placebo n=3 Participants Participants with TBI who were randomized to receive Placebo	Control Participants Who Received CDP-Choline n=3 Participants Participants without a history of TBI who were randomized to receive CDP-Choline	Control Participants Who Received Placebo n=2 Participants Participants without a history of TBI who were randomized to receive placebo
Cognitive Composite Score for Group of Subjects With TBI and Unmatched Healthy Controls	55.750 T-score Interval 46.187 to 65.313	50.167 T-score Interval 42.358 to 57.975	53.000 T-score Interval 45.192 to 60.808	55.000 T-score Interval 45.437 to 64.563

Adverse Events

Participants With TBI Who Received CDP-Choline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Participants With TBI Who Received Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Participants Who Received CDP-Choline

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Participants Who Received Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Participants With TBI Who Received CDP-Choline n=3 participants at risk Participants who have experienced a TBI and were randomly assigned to receive the study supplement	Participants With TBI Who Received Placebo n=2 participants at risk Participants with a history of TBI who were randomly assigned to the placebo group	Control Participants Who Received CDP-Choline n=7 participants at risk Individuals without a history of TBI who acted as control participants and were randomly assigned to receive CDP-Choline	Control Participants Who Received Placebo n=3 participants at risk Individuals without a history of TBI who participated as control subjects and were randomly assigned to receive placebo
Social circumstances Car Accident	33.3% 1/3 • Number of events 1	0.00% 0/2	0.00% 0/7	0.00% 0/3
Nervous system disorders Migraine	0.00% 0/3	0.00% 0/2	14.3% 1/7 • Number of events 1	0.00% 0/3
Nervous system disorders Headaches (daily)	0.00% 0/3	0.00% 0/2	14.3% 1/7 • Number of events 1	0.00% 0/3

Additional Information

Patricia M Arenth PhD

University of Pittsburgh

Phone: 412-648-6666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place