HealthyNCT02705066
Citicoline Effects on Cortical Membrane Structure and Function
A study testing Citicoline supplement in people with Healthy, run by Kyowa Hakko Bio Co., Ltd. at 1 site in United States.
Trial summary
The goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults. Read more about this study
- Who is it for?
- Ages 40 to 60 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
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jul 2018
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent;
- Ages 40-60 years old;
- Right handed.
- If female, not pregnant (as determined by a positive pregnancy test); and agrees to use one of the following methods of birth control: abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive;
Who cannot join
- Contraindication to an MRI scan (i.e., braces, claustrophobia, pacemaker etc);
- A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy);
- Body mass index (BMI) ≥ 30;
- An IQ <75 and >130;
- A positive urine drug test (nicotine dependence is permitted);
- Personal history of a DSM-5 Axis I psychiatric disorder;
- Requiring treatment with a drug which might obscure the action of the study treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults.
Read the detailed description
To determine the effect of citicoline supplementation on cortical structure and function in healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo on event-related anterior cingulate cortex (ACC) activation during sustained attention by fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by 31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS) following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and ACC activation, ACC PDE levels, or the effects of citicoline.
- Conditions
- Healthy
- Being tested
- Citicoline supplement, Placebo supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citicoline supplementDietary supplement
Also called Cognizin
Placebo supplementDietary supplement
Also called Placebo
Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Cellulose) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo supplement |
| Cognizin 250 mg/day | Experimental | Not described Receives: Dietary Supplement: Citicoline supplement |
| Cognizin 500 mg/day | Experimental | Not described Receives: Dietary Supplement: Citicoline supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phosphodiester (PDE) concentrations in the ACC by 31P-MRS
Measured: 6 weeks
b-NTP concentrations in the ACC by 31P-MRS
Measured: 6 weeks
Secondary outcomes (3)
Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI
Measured: 6 weeks
Reaction time (ms) on an attention task (CPT-IP)
Measured: 6 weeks
Accuracy (percent correct) on an attention task (CPT-IP)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2018
- Study completionJul 2018
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Hakko Bio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705066
- Sponsor's protocol ID
- 2015-8400
- Status last verified
- Feb 2019
- First submitted
- 23 Feb 2016
- Last updated
- 23 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Citicoline Effects on Cortical Membrane Structure and Function
- ClinicalTrials.gov ID
- NCT02705066
- Acronym / sponsor ID
- 2015-8400
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kyowa Hakko Bio Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Cincinnati
- Study start
- Mar 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 Mar 2016 (estimated)
- 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 goal of this project is to determine the effects of 6-week dietary supplementation with one of two doses of citicoline (250 mg/d, 500 mg/d) or placebo on prefrontal cortical membrane dynamics (31P-MRS) and event-related functional activation (fMRI) in healthy middle-aged adults.
Detailed description
To determine the effect of citicoline supplementation on cortical structure and function in healthy middle-aged adults. Test 1: The effect of citicoline (500 mg/d) compared with placebo on event-related anterior cingulate cortex (ACC) activation during sustained attention by fMRI. Test 2: The effect of citicoline (500 mg/d) compared with placebo on reaction time and increasing accuracy on the sustained attention task (CPT-IP). Test 3: The effect of citicoline compared with placebo on phosphodiester (PDE) and b-NTP levels in the ACC by 31P-MRS. Test 4: ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS) following high-dose citicoline (500 mg/d) compared with placebo at Week 3. Test 5: The effect of low-dose citicoline (250 mg/d) compared with placebo on an ACC activation and CPT-IP performance (fMRI) and ACC PDE levels (31P-MRS). Test 6: Among all subjects (n=60), the relationship between baseline red blood cell (RBC) omega-3 fatty acid (EPA+DHA) levels and ACC activation, ACC PDE levels, or the effects of citicoline.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (Cellulose) | Placebo comparator | Dietary Supplement: Placebo supplement |
| Cognizin 250 mg/day | Experimental | Dietary Supplement: Citicoline supplement |
| Cognizin 500 mg/day | Experimental | Dietary Supplement: Citicoline supplement |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of written informed consent;
- Ages 40-60 years old;
- Right handed.
- If female, not pregnant (as determined by a positive pregnancy test); and agrees to use one of the following methods of birth control: abstinence from sexual intercourse, barrier (diaphragm or condom), or oral/injectable contraceptive;
Key exclusion criteria (7 listed)
- Contraindication to an MRI scan (i.e., braces, claustrophobia, pacemaker etc);
- A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy);
- Body mass index (BMI) ≥ 30;
- An IQ <75 and >130;
- A positive urine drug test (nicotine dependence is permitted);
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 |
|---|---|---|
| Citicoline supplementAlso: Cognizin | Dietary supplement | Cognizin 250 mg/day, Cognizin 500 mg/day |
| Placebo supplementAlso: PlaceboCellulose | Dietary supplement | Placebo (Cellulose) |
Primary outcome
Phosphodiester (PDE) concentrations in the ACC by 31P-MRS
Time frame: 6 weeks
b-NTP concentrations in the ACC by 31P-MRS
Time frame: 6 weeks
3 secondary outcomes
Blood oxygenation level-dependent signal in the ACC during sustained attention by fMRI
Time frame: 6 weeks
Reaction time (ms) on an attention task (CPT-IP)
Time frame: 6 weeks
Accuracy (percent correct) on an attention task (CPT-IP)
Time frame: 6 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 23 May 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kyowa Hakko Bio Co., Ltd. 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 4 inclusion and 7 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 23 May 2019. 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?
Phosphodiester (PDE) concentrations in the ACC by 31P-MRS (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 23 May 2019.