Citicoline Effects on Cortical Membrane Structure and Function

May 21, 2019 updated by: Kyowa Hakko Bio Co., Ltd.
The goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the effect of citicoline supplementation on cortical structure and function in healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo on event-related anterior cingulate cortex (ACC) activation during sustained attention by fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by 31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS) following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and ACC activation, ACC PDE levels, or the effects of citicoline.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States
        • University of Cincinnati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of written informed consent;
  • Ages 40-60 years old;
  • Right handed.
  • If female, not pregnant (as determined by a positive pregnancy test); and agrees to use one of the following methods of birth control: abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive;

Exclusion Criteria:

  • Contraindication to an MRI scan (i.e., braces, claustrophobia, pacemaker etc);
  • A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy);
  • Body mass index (BMI) ≥ 30;
  • An IQ <75 and >130;
  • A positive urine drug test (nicotine dependence is permitted);
  • Personal history of a DSM-5 Axis I psychiatric disorder;
  • Requiring treatment with a drug which might obscure the action of the study treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (Cellulose)
Dietary supplement: Placebo supplement
Cellulose
Other Names:
  • Placebo
Experimental: Cognizin 250 mg/day
Dietary supplement: Citicoline supplement
Other Names:
  • Cognizin
Experimental: Cognizin 500 mg/day
Dietary supplement: Citicoline supplement
Other Names:
  • Cognizin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phosphodiester (PDE) concentrations in the ACC by 31P-MRS
Time Frame: 6 weeks
6 weeks
b-NTP concentrations in the ACC by 31P-MRS
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI
Time Frame: 6 weeks
6 weeks
Reaction time (ms) on an attention task (CPT-IP)
Time Frame: 6 weeks
6 weeks
Accuracy (percent correct) on an attention task (CPT-IP)
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Hakko Bio Co., Ltd.

Collaborators

University of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 6, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-8400

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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