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

Completed · Phase 2 · Has a placebo group

Conditions studied: Brain Injuries

In brief

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.

Key facts

Study ID

NCT00727246

Run by

Patricia M. Arenth

People needed

19

Starts

2009-03-01

Expected to finish

2013-05-01

Last updated by the study team

2017-07-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For individuals with TBI and Health Controls:
• right hand dominant
• English speaking
• No history of neurological illness (for example, stroke, seizure or brain tumor.
• No significant history of psychiatric illness (for example, schizophrenia or bipolar disorder) or current severe emotional distress.
• No visual difficulties that would not allow for reading and following written instructions.
• Free of alcohol or substance abuse.
• Capable of following basic written and oral instructions.
• Not taking certain medications that may interact with study medication or interfere with neuroimaging.
• Be able to take medication in tablet form, or crushed and dissolved in a liquid.
• Meet the additional criteria associated with MRI safety standards, as required by the University of Pittsburgh Department of Radiology. For example, these criteria include exclusion due to surgical placement of metal plates or electronic implants.
• In addition:
• Individuals with TBI must:
• Have a specific diagnosis of a moderate to severe traumatic brain injury, which can be confirmed through review of medical records or assessments.
• Be at least 1 year, but no more than 3 years since injury.
• Must have significant working memory problems, as indicated by performance on a screening test.
• Normal Control subjects must:
• Perform within the normal range on a test of working memory.

You may not qualify if…

• Prisoners.
• Males with sexual partners who are planning to become pregnant during the treatment period.
• Females who are currently pregnant or who are planning to become pregnant during the treatment period.
• Individuals who are currently enrolled in another medication study
• Individuals who are currently, or have previously been, treated with CDP-Choline (Citicoline) for research or clinical purposes.
• Currently in a nursing home in the state of Pennsylvania.

Where it is running

• University of Pittsburgh, Department of Physical Medicine & Rehabilitation — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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