Evaluate the Effects of Citicoline on Cognitive Performance in Healthy Adults

NCT06906848 | Completed

• 1 other identifier: K05-24-01-T0060
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Cognizin is a patented form of citicoline, a natural compound of the brain tissue. It is believed that Cognizin can support brain function by boosting brain energy and protecting brain cells. Research suggests that Cognizin can improve different aspects of brain function and affects cognitive performance in healthy adults.

Conditions

Healthy; Cognitive Performance

Keywords

Citicoline; Cognitive; cognitive performance

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of the Test Product (TP) on cognitive performance compared to a placebo after 12 weeks using the Psychomotor Vigilance Test (PVT)

  12 weeks

Secondary Outcomes (2)

• To evaluate the effect of the TP on attention control to a placebo after 12 weeks using the Stroop squared task, Flanker squared task and Simon squared task.

  12 weeks

• To evaluate the effect of the TP on motor speed to a placebo after 12 weeks by using the Finger-Tapping test.

  12 weeks

Other Outcomes (1)

• To assess the safety and tolerability of the TP in healthy participants: Reports of Adverse Events To determine number of participants with adverse events.

  0-12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Active ingredients: none

Dietary Supplement: Placebo

Cognizin®

ACTIVE COMPARATOR

Active ingredients: Citicoline

Dietary Supplement: Cognizin®

Interventions

Placebo DIETARY_SUPPLEMENT

Oral

Placebo

Cognizin® DIETARY_SUPPLEMENT

Oral

Also known as: Citicoline supplement

Cognizin®

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and females who are 18-35 years of age (inclusive) at screening.
• Body mass index (BMI) between 18.0 to 34.9 kg/m2 (inclusive).
• In good general health and are able to swallow capsules.
• Participants agree to maintain their usual caffeine consumption habits.
• Participants who have habitually eaten breakfast for at least 1 month before screening, and agree to eat breakfast daily, and take study product with this meal when applicable as instructed, for the duration of the study.
• MMSE score \>24 at screening.
• Naïve to oral cannabis or hemp, or light user of oral cannabis or hemp products (not more than 2 times per month on average).
• Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study- related procedures.

You may not qualify if:

• Females who are lactating, pregnant or planning to become pregnant during the study.
• Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• Are receiving treatments, or have been hospitalized in the last 12 months, for psychiatric disorders and/or brain-related medical conditions.
• Participants who have habitually used any nicotine-containing products in the past 6 months before screening.
• Individuals with any pre-existing neuromuscular disorder, physical disability, or injury.
• Have inadequate sleep schedule defined as an average of less than 6 hours per night.
• Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease
• Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised.
• Currently have cancer or have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurred at least 5 years before the screening visit.
• Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing and digestion.
• Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product.
• Reports a clinically significant illness during the 28 days before the first dose of study product.
• Major surgery in 3 months prior to screening or planned major surgery during the study.
• Currently consumes more than two (2) standard alcoholic beverages per day on average for the two weeks prior to screening.
• Have a history of alcohol or substance abuse in the 12 months prior to screening

Sponsors & Collaborators

• Kirin Holdings Company, Limited: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Apex Trials

Guelph, Ontario - on, N1G 0B4, Canada

Location

Study Officials

• Dr.Koichiro Murashima

  Kirin Holding Company Ltd. - Institute of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo will match the TP in physical and visual appearance and packaging and each participant's study product assignments will be associated with a unique code to prevent premature unblinding. Planned unblinding will occur following database lock, definition of study populations, and a blinded statistical analysis Delegated unblinded site personnel will be responsible for study product accountability, reconciliation, and record maintenance (i.e., receipt, reconciliation, and final disposition records) throughout the course of the study. The investigator will have oversight in a blinded manner.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are 2 study groups, including one test product (TP) group and one placebo (PL) group.

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: November 20, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 20, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)