CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
CDP-Choline +1 moredrug
Likely dose
CDP-Choline 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00727246
NCT00727246Phase 2Completed

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

Patricia M. Arenth·interventional·Posted Aug 1, 2008·Updated Jul 28, 2017

In Brief

A Phase 2 clinical trial evaluating CDP-Choline and Placebo for Brain Injuries. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether an investigational drug, called "CDP-Choline", improves memory in people with traumatic brain injury (TBI). To do this, we are asking for people with traumatic brain injury and people without traumatic brain injury to be a part of this study. We will compare results between each group to see if this investigational drug makes a difference with memory. We will also compare brain imaging results and information collected before and after the taking of the study medication to see if there are any differences. We hypothesize that there will be differences in brain activation patterns between individuals with TBI and healthy controls, as well as differences in performance on memory testing at baseline. We further hypothesize that, after treatment with CDP-Choline, the patterns in neuroimaging findings and cognitive testing results for individuals with TBI will more closely resemble results observed for healthy individuals. We hope that what we learn from this study will be helpful in the future treatment of individuals with head injury.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Injuries
CountriesUnited States

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2008
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 17.9 years ago

Interventions

CDP-Cholinedrug

1000 mg CDP-Choline 2 x per day for 6 weeks.

Placebodrug

Treatment with placebo for 6 weeks