Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPlacebo supplement
Cellulose
DIETARY_SUPPLEMENTCiticoline supplement
Cognizin ®
Sponsors
Biofortis Clinical Research, Inc.
Kirin Holdings Company, Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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 | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment | 12 weeks |
Countries
United States
Outcome results
None listed