Cognitive Effects of Citicoline on Attention in Healthy Mean and Women

Last updated: April 3, 2025
Sponsor: Kirin Holdings Company, Limited
Overall Status: Completed

Phase

N/A

Condition

Brain Function

Treatment

Placebo

Placebo supplement

Citicoline supplement

Clinical Study ID

NCT04967157
BIO-2104
  • Ages 35-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of this trial is to determine the effects of citicoline on cognitive performance for attention in healrhy Men and Women compared to a placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female, 35-75 years of age

  • Scores ≥ 24 on the MMSE, ≤15 on the CESD-R, and scores below the population median (i.e., below 81.25, above 36.8) on the Gradual CPT

  • Self-reported poor attention

  • no health conditions that would prevent him or her from fulfilling the studyrequirements on the basis of medical history and routine laboratory test results

  • Understands the study procedures and signs forms providing informed consent toparticipate in the study and authorizes the release of relevant protected healthinformation to the Principal Investigator.

Exclusion

Exclusion Criteria:

  • color blindness

  • Known allergy or sensitivity to any of the ingredients in the study products and/orany ingredients of the breakfast meal provided

  • major medical or neurological illness

  • diagnosis of attention deficit hyperactive disorder (ADHD)

  • female who is pregnant, planning to be pregnant during the study period

  • requiring treatment with a drug which might obscure the action of the studytreatment

Study Design

Total Participants: 148
Treatment Group(s): 4
Primary Treatment: Placebo
Phase:
Study Start date:
September 08, 2021
Estimated Completion Date:
August 31, 2022

Study Description

This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women. Cognitive assessments will be performed to determine whether citicoline administration improves attention, compared to placebo administration.

**Note: This note is to inform you that the Unique Protocol ID BIO-2104 was unintentionally combined with another Unique Protocol ID, K5-24-01-T0060, resulting in history records that should not be considered as part of the BIO-2104's timeline.

This explanation has been added per PRS instructions to ensure compliance and maintain data integrity in alignment with the protocol.

Connect with a study center

  • Apex Trials

    Guelph, Ontario - ON N1G 0B4
    Canada

    Site Not Available

  • Biofortis Clinical Research, Inc.

    Addison, Illinois 60101
    United States

    Site Not Available

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