Cognitive Effects of Citicoline on Attention in Healthy Mean and Women

NCT ID: NCT04967157

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-08
• Study Completion Date: 2022-08-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Intervention: Dietary Supplement: Placebo supplement

Group Type: PLACEBO_COMPARATOR

Placebo supplement

Intervention Type: DIETARY_SUPPLEMENT

Cellulose

Cognizin®

Intervention: Dietary Supplement: Citicoline supplement

Group Type: EXPERIMENTAL

Citicoline supplement

Intervention Type: DIETARY_SUPPLEMENT

Cognizin ®

Interventions

Placebo supplement

Cellulose

Intervention Type: DIETARY_SUPPLEMENT

Citicoline supplement

Cognizin ®

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo; Cognizin ®

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biofortis Clinical Research, Inc.

INDUSTRY

Sponsor Role: collaborator

Kirin Holdings Company, Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Kelley, MD

Role: PRINCIPAL_INVESTIGATOR

Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101

Locations

Biofortis Clinical Research, Inc.

Addison, Illinois, United States

Countries

United States

Other Identifiers

BIO-2104

Identifier Type: -

Identifier Source: org_study_id