Cognitive Effects of Citicoline on Attention in Healthy Mean and Women

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Cognizin®

• Registration Number: NCT04967157
• Lead Sponsor: Kirin Holdings Company, Limited

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-08
• Study First Posted: 2021-07-19
• Study Start: 2021-09-08
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Active ingredients: none
Cognizin®	Cognizin®	Active ingredients: Citicoline

Primary Outcome Measures

Name	Time	Method
Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment	12 weeks

Secondary Outcome Measures

Name	Time	Method
Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment	12 weeks

Trial Locations

Locations (1)

Biofortis Clinical Research, Inc.; 🇺🇸 Addison, Illinois, United States