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Completed

NCT Number: NCT04967157

Cognitive Effects of Citicoline on Attention in Healthy Mean and Women

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.

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Key information

Conditions

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis Clinical Research, Inc.

Addison, Illinois, 60101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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 study requirements on the basis of medical history and routine laboratory test results
  • Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Principal Investigator.

Exclusion criteria

  • color blindness
  • Known allergy or sensitivity to any of the ingredients in the study products and/or any 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 study treatment

Treatment and study plan

Placebo supplement

Dietary Supplement

Cellulose

Other names: Placebo

Citicoline supplement

Dietary Supplement

Cognizin ®

Other names: Cognizin ®

Primary outcomes

  1. Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment

    Time frame: 12 weeks

Secondary outcomes

  1. Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Kirin Holdings Company, Limited

Industry

Collaborators

  • Biofortis Clinical Research, Inc.

Registry information

Official study title

A Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Cognitive Effects of a Citicoline Supplement (Cognizin®) on Attention in Healthy Men and Women

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2021
Registry last updated
Apr 6, 2025

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.

Published trials that share one or more normalized conditions with this study.