Cognitive Effects of Citicoline on Attention in Healthy Men and Women

March 7, 2023 updated by: Kirin Holdings Company, Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Intervention: Dietary Supplement: Placebo supplement
Dietary supplement: Placebo supplement
Cellulose
Other Names:
  • Placebo
Experimental: Cognizin®
Intervention: Dietary Supplement: Citicoline supplement
Dietary supplement: Citicoline supplement
Cognizin®
Other Names:
  • Cognizin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirin Holdings Company, Limited

Collaborators

Biofortis Clinical Research, Inc.

Investigators

  • Principal Investigator: Kathleen Kelley, MD, Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

August 31, 2022

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIO-2104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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