HealthyNCT04967157
Cognitive Effects of Citicoline on Attention in Healthy Mean and Women
A study testing Citicoline supplement in people with Healthy, run by Kirin Holdings Company, Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Citicoline supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 31 Aug 2022
- 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 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research, Inc.
Addison, Illinois, 60101
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Placebo supplement, Citicoline supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo supplementDietary supplement
Also called Placebo
Cellulose
Citicoline supplementDietary supplement
Also called Cognizin ®
Cognizin ®
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intervention: Dietary Supplement: Placebo supplement Receives: Dietary Supplement: Placebo supplement |
| Cognizin® | Experimental | Intervention: Dietary Supplement: Citicoline supplement Receives: Dietary Supplement: Citicoline supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment
Measured: 12 weeks
Secondary outcomes (1)
Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment
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 posted19 Jul 2021
- Study start8 Sep 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirin Holdings Company, Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Kathleen Kelley, MD, Principal investigator, Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967157
- Sponsor's protocol ID
- BIO-2104
- Status last verified
- Mar 2023
- First submitted
- 8 Jul 2021
- Last updated
- 6 Apr 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04967157
- Acronym / sponsor ID
- BIO-2104
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Kirin Holdings Company, LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Jul 2021 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo supplementIntervention: Dietary Supplement: Placebo supplement |
| Cognizin® | Experimental | Dietary Supplement: Citicoline supplementIntervention: Dietary Supplement: Citicoline supplement |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Placebo supplementAlso: PlaceboCellulose | Dietary supplement | Placebo |
| Citicoline supplementAlso: Cognizin ®Cognizin ® | Dietary supplement | Cognizin® |
Primary outcome
Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment
Time frame: 12 weeks
1 secondary outcome
Standardized scores on the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment
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 6 Apr 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.
Kathleen Kelley, MD principal investigator
Biofortis Clinical Research, Inc. Addison, Illinois, United States, 60101
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citicoline supplement in people with Healthy, run by Kirin Holdings Company, Limited at 1 site in United States.
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 5 inclusion and 6 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 6 Apr 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 United States. 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?
Composite score calculated based on scores from the Computerized Mental Performance Assessment System (COMPASS, Northumbria University, Newcastle upon Tyne, UK) that measure cognitive assessment (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 6 Apr 2025.