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Completed

NCT Number: NCT02705066

Citicoline Effects on Cortical Membrane Structure and Function

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.

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Key information

Conditions

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati

Cincinnati, Ohio, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Citicoline supplement

Dietary Supplement

Other names: Cognizin

Placebo supplement

Dietary Supplement

Cellulose

Other names: Placebo

Primary outcomes

  1. Phosphodiester (PDE) concentrations in the ACC by 31P-MRS

    Time frame: 6 weeks

  2. b-NTP concentrations in the ACC by 31P-MRS

    Time frame: 6 weeks

Secondary outcomes

  1. Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI

    Time frame: 6 weeks

  2. Reaction time (ms) on an attention task (CPT-IP)

    Time frame: 6 weeks

  3. Accuracy (percent correct) on an attention task (CPT-IP)

    Time frame: 6 weeks

Other outcomes

  1. Baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Kyowa Hakko Bio Co., Ltd.

Industry

Collaborators

  • University of Cincinnati

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 10, 2016
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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