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

NCT00727246 | Completed Phase 2 Results DMC

• 2 other identifiers: PRO07020121K23HD049626
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Injuries

Keywords

Traumatic Brain Injury; FMRI; Memory; Cognition; Neuropsychology

Outcome Measures

Primary Outcomes (2)

• Cognitive Composite Score for Group of Subjects With TBI and Healthy Controls Matched by Age, Education, and Treatment 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. 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.

  6 weeks

• Cognitive Composite Score for Group of Subjects With TBI and Unmatched Healthy Controls

  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.

  6 weeks

Study Arms (2)

CDP-Choline

EXPERIMENTAL

Treatment with CDP-Choline

Drug: CDP-Choline

Placebo

PLACEBO COMPARATOR

Treatment with Placebo

Drug: Placebo

Interventions

CDP-Choline DRUG

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

Also known as: Citicoline, Cytidine 5'-diphosphocholine

CDP-Choline

Placebo DRUG

Treatment with placebo for 6 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.
• 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.

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.

Sponsors & Collaborators

• Patricia M. Arenth: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh, Department of Physical Medicine & Rehabilitation

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Links

• University of Pittsburgh School of Medicine, Department of Physical Medicine \& Rehabilitation

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Cytidine Diphosphate; Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Limitations and Caveats

Due to multiple complex issues, recruitment was significantly lower than anticipated. As a result, statistical analyses are presented, however the number of subjects in each comparison group was very low and results should be considered with caution

Results Point of Contact

• Title: Patricia M Arenth PhD
• Organization: University of Pittsburgh

arenpm@upmc.edu

412-648-6666

Study Officials

• Patricia M. Arenth, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: March 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 28, 2017
• Results First Posted: July 28, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)