HealthyNCT06906848
Evaluate the Effects of Citicoline on Cognitive Performance in Healthy Adults
A study testing Cognizin® in people with Healthy and Cognitive Performance, run by Kirin Holdings Company, Limited at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cognitive Performance
- What is being tested?
- Cognizin®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 20 Nov 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Effects of Cognizin ® Citicoline on Cognitive Performance in Generally Healthy Adults
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.
Read the detailed description
This study is a prospective, randomized, placebo-controlled, double-blind trial designed to assess the effects of Cognizin on cognitive performance in healthy young adults.
Participants will be randomized in a 1:1 ratio to either the test product (TP) or placebo (PL). During the study, participants cognitive performance will be assessed using the Psychomotor Vigilance Test (PVT) at baseline and after 12 weeks.
Safety assessments will be conducted throughout the study.
Note: The Unique Protocol ID K05-24-01-T0060 was unintentionally combined with another Unique Protocol ID, Bio-2104. As a result, the first protocol record for K05-24-01-T0060 was released in September 2024, prior to participant recruitment and randomization. The study start date was November 2024.
This explanation has been added per PRS instructions to ensure compliance and maintain data integrity in alignment with the protocol.
- Conditions
- Healthy, Cognitive Performance
- Being tested
- Placebo, Cognizin®
- Keywords
- Citicoline, Cognitive, cognitive performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Oral
Cognizin®Dietary supplement
Also called Citicoline supplement
Oral
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Active ingredients: none Receives: Dietary Supplement: Placebo |
| Cognizin® | Active comparator | Active ingredients: Citicoline Receives: Dietary Supplement: Cognizin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 weeks
To evaluate the effect of the TP on motor speed to a placebo after 12 weeks by using the Finger-Tapping test.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start20 Nov 2024
- Primary completion31 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 study groups, including one test product (TP) group and one placebo (PL) group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirin Holdings Company, Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Dr.Koichiro Murashima, Study chair, Kirin Holding Company Ltd. - Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906848
- Sponsor's protocol ID
- K05-24-01-T0060
- Status last verified
- Jul 2025
- First submitted
- 26 Mar 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Effects of Cognizin ® Citicoline on Cognitive Performance in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT06906848
- Acronym / sponsor ID
- K05-24-01-T0060
- Conditions
- Healthy, Cognitive Performance
- Keywords
- Citicoline, Cognitive, cognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kirin Holdings Company, LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, randomized, placebo-controlled, double-blind trial designed to assess the effects of Cognizin on cognitive performance in healthy young adults.
Participants will be randomized in a 1:1 ratio to either the test product (TP) or placebo (PL). During the study, participants cognitive performance will be assessed using the Psychomotor Vigilance Test (PVT) at baseline and after 12 weeks.
Safety assessments will be conducted throughout the study.
Note: The Unique Protocol ID K05-24-01-T0060 was unintentionally combined with another Unique Protocol ID, Bio-2104. As a result, the first protocol record for K05-24-01-T0060 was released in September 2024, prior to participant recruitment and randomization. The study start date was November 2024.
This explanation has been added per PRS instructions to ensure compliance and maintain data integrity in alignment with the protocol.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- There are 2 study groups, including one test product (TP) group and one placebo (PL) group.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboActive ingredients: none |
| Cognizin® | Active comparator | Dietary Supplement: Cognizin®Active ingredients: Citicoline |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOral | Dietary supplement | Placebo |
| Cognizin®Also: Citicoline supplementOral | Dietary supplement | Cognizin® |
Primary outcome
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)
Time frame: 12 weeks
2 secondary outcomes
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.
Time frame: 12 weeks
To evaluate the effect of the TP on motor speed to a placebo after 12 weeks by using the Finger-Tapping test.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Koichiro Murashima study chair
Kirin Holding Company Ltd. - Institute of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognizin® in people with Healthy and Cognitive Performance, run by Kirin Holdings Company, Limited at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.