Cognitive Effects of Citicoline on Attention in Healthy Mean and Women

NCT04967157 | Completed

• 1 other identifier: BIO-2104
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Intervention: Dietary Supplement: Placebo supplement

Dietary Supplement: Placebo supplement

Cognizin®

EXPERIMENTAL

Intervention: Dietary Supplement: Citicoline supplement

Dietary Supplement: Citicoline supplement

Interventions

Placebo supplement DIETARY_SUPPLEMENT

Cellulose

Also known as: Placebo

Placebo

Citicoline supplement DIETARY_SUPPLEMENT

Cognizin ®

Also known as: Cognizin ®

Cognizin®

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirin Holdings Company, Limited: lead
• Biofortis Clinical Research, Inc.: collaborator

Study Sites (1)

Biofortis Clinical Research, Inc.

Addison, Illinois, 60101, United States

Location

Study Officials

• Kathleen Kelley, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 19, 2021
• Study Start: September 8, 2021
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: April 6, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)