Clinical trial NCT04967157: Cognitive Effects of Citicoline on Attention in Healthy Mean and Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Kirin Holdings Company, Limited
Sponsor class: INDUSTRY
Collaborators: name: Biofortis Clinical Research, Inc.
First posted: 2021-07-19
Enrollment: 148
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Clinical Research, Inc.
state: Illinois
Study officials:
affiliation: Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101
name: Kathleen Kelley, MD
role: PRINCIPAL_INVESTIGATOR
References: