Evaluate the Effects of Citicoline on Cognitive Performance in Healthy Adults

Launched by KIRIN HOLDINGS COMPANY, LIMITED · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special form of citicoline called Cognizin on brain function in healthy adults. Citicoline is a natural compound that may help improve how our brains work by providing energy and protecting brain cells. Researchers believe that taking Cognizin could lead to better cognitive performance, which includes things like memory, attention, and problem-solving skills.

To join the study, participants need to be healthy adults aged between 18 and 35, with a body mass index (BMI) in a specific range. They should be in good health, able to swallow capsules, and agree to eat breakfast daily while taking the study product. However, there are some important exclusions, such as those who are pregnant, have certain medical conditions, or have recently used nicotine or cannabis products. If eligible, participants can expect to take Cognizin and complete some assessments related to their cognitive performance throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy adult males and females who are 18-35 years of age (inclusive) at screening.
• • 2. Body mass index (BMI) between 18.0 to 34.9 kg/m2 (inclusive).
• • 3. In good general health and are able to swallow capsules.
• • 4. Participants agree to maintain their usual caffeine consumption habits.
• • 5. 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.
• • 6. MMSE score \>24 at screening.
• • 7. Naïve to oral cannabis or hemp, or light user of oral cannabis or hemp products (not more than 2 times per month on average).
• • 8. 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.
• Exclusion Criteria:
• • 1. Females who are lactating, pregnant or planning to become pregnant during the study.
• • 2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• • 3. Are receiving treatments, or have been hospitalized in the last 12 months, for psychiatric disorders and/or brain-related medical conditions.
• • 4. Participants who have habitually used any nicotine-containing products in the past 6 months before screening.
• • 5. Individuals with any pre-existing neuromuscular disorder, physical disability, or injury.
• • 6. Have inadequate sleep schedule defined as an average of less than 6 hours per night.
• • 7. Have Type I diabetes, uncontrolled Type II diabetes, uncontrolled high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease
• • 8. Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised.
• • 9. 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.
• • 10. Have an abnormality or obstruction of the gastrointestinal tract precluding swallowing and digestion.
• • 11. Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product.
• • 12. Reports a clinically significant illness during the 28 days before the first dose of study product.
• • 13. Major surgery in 3 months prior to screening or planned major surgery during the study.
• • 14. Currently consumes more than two (2) standard alcoholic beverages per day on average for the two weeks prior to screening.
• • 15. Have a history of alcohol or substance abuse in the 12 months prior to screening
• • 16. Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer.
• • 17. Any other medical condition/situation or use of medications/ supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.