Cognitive Effects of Citicoline on Attention in Healthy Men and Women

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04967157
• Other study ID #: BIO-2104
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Healthy

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