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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04967157
Other study ID # BIO-2104
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 8, 2021
Est. completion date August 31, 2022

Study information

Verified date March 2023
Source Kirin Holdings Company, Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo supplement
Cellulose
Citicoline supplement
Cognizin®

Locations

Country Name City State
United States Biofortis Clinical Research, Inc. Addison Illinois

Sponsors (2)

Lead Sponsor Collaborator
Kirin Holdings Company, Limited Biofortis Clinical Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment 12 weeks
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