Mild Cognitive ImpairmentNCT05690724
Exploratory Trial in Healthy Adults With Mild Cognitive Impairment,16-week Intervention With Mitocholine™
A study of Mild Cognitive Impairment, run by Mitocholine Ltd at 1 site in Ireland.
Trial summary
To evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment. The study will also include measures of memory, language, S-adenosylmethionone (SAM), Betaine, Choline. Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 9 Jan 2023to 31 Aug 2024
- 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 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate in the study and comply with its procedures.
- Able to give written informed consent.
- Adults aged 55 to 79 years, inclusive.
- Meet MCI criteria, based on the Peterson criteria (Peterson et al., 1999):
- Objective evidence of cognitive impairment as assessed by MoCA (score ≥18 to ≤25).
- Absence of major depression as assessed by PHQ (score <10).
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- Activities of daily living score
- males ≥4
- females ≥7
- Have a homocysteine level ≥11.0μmol/L (Smith D et al, 2018).
Who cannot join
- Diagnosis of a major cognitive disorder (e.g. Alzheimer's or Parkinson's disease diagnoses; additionally, confirmation of a mini stroke (TIA) within the last 3 months would be an exclusionary condition).
- Participants who are pregnant or wish to become pregnant during the trial.
- Participants who are lactating and/or currently breastfeeding.
- Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator.
- Participants with active or a history of alcohol or substance abuse; (exclude elevated Gamma GT \& clinically abnormal liver function test).
- Uncontrolled diabetes (or glycated haemoglobin >7% / 53 mmol/mol).
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- Clinically significant heart, liver, or renal disease (at the discretion of the investigator).
- Have uncontrolled hypertension SBP > 160mmHg, DBP > 100mmHg).
- Participants prescribed medications likely to influence memory or mood, as determined by the investigator.
- Participants with a history of depression (within past 24 months) or any concurrent medical, cognitive or psychiatric condition that would either: compromise his/her ability to comply with the study requirements, may pose significant risk to the participant, or be deemed exclusionary by the investigator
- Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results.
- Change in supplements, medication, or major diet in 30 days prior to enrolment and throughout the study.
- Taking any supplements or vitamins notably known to affect cognitive function (e.g. Living Nutrition Cognitive, Viridian Cognitive Complex, ginkgo biloba, fish oil etc., list not exhaustive), or any psychotropic medications and products which interact with acetylcholine esterase and/or NMDA receptors (6-week washout before screening). Vitamin D and Calcium supplements permitted if on a stable dose for the previous 3 months.
- Users of inhaled nicotine products such as cigarettes or vape products with an inconsistent recent history of consumption i.e., those who have taken up smoking/vaping in the 12 months prior to screening, or those who have either given up or re-started smoking or vaping in the 12 months prior to screening, or those who intend to significantly modify their use of inhaled nicotine products during their participation in the study.
- Has received treatment involving experimental drugs in the past 3 months.
- Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study.
- Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
- Any Participant who is an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Study in Otherwise Healthy Adults With Mild Cognitive Impairment (MCI) Assessing a 16-week Intervention With Mitocholine™, a Functional Food Ingredient
To evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment. The study will also include measures of memory, language, S-adenosylmethionone (SAM), Betaine, Choline.
Read the detailed description
A randomised, double-blind, placebo-controlled, parallel-group study in otherwise healthy adults with Mild Cognitive Impairment (MCI).
Assessing a 16-week intervention with Mitocholine™, a functional food ingredient to evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment.
The primary hypotheses being that there will be a significant change in Executive Function scores as measured by Delis Kaplan Executive Function Score (DKEFS) and in homocysteine levels.
The study will also include measures of memory, language, S-adenosylmethionone (SAM), Betaine, Choline.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Mitocholine™ or Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitocholine™ or PlaceboDietary supplement
Participants will be instructed to consume one bottle of study product daily for the duration of the trial (16 weeks). They will be instructed to consume the product in the morning with breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Mitocholine™ | Experimental | Mitocholine™ is a novel formulation of three nutrients choline, succinic acid, and nicotinamide (a vitamin B3) Receives: Dietary Supplement: Mitocholine™ or Placebo |
| Placebo | Placebo comparator | The Placebo product will be identical in appearance and taste to the investigational product Receives: Dietary Supplement: Mitocholine™ or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in Executive Function Score in the Mitocholine group compared to the Placebo group.
Assessed by the verbal fluency, colour-word interference and trail making tests in the Delis-Kaplan Executive Function System (Composite Score)
Measured: Baseline to end of intervention (week 16)
Absolute change in Homocysteine levels in the Mitocholine group compared to the Placebo group.
Assessed by serum Homocysteine levels (umol/L)
Measured: Baseline to end of intervention (week 16)
Secondary outcomes (9)
Change in Choline levels in the Mitocholine group compared to the Placebo group
Assessed by Choline in blood
Measured: Baseline to end of intervention (week 16)
Change in S-adenosylmethionone (SAM) levels in the Mitocholine group compared to the Placebo group
Assessed by S-adenosylmethionone (SAM) in blood
Measured: Baseline to end of intervention (week 16)
Change in Betaine levels in the Mitocholine group compared to the Placebo group
Assessed by Betine in blood
Measured: Baseline to end of intervention (week 16)
Change in Memory outcomes (visual memory) in the Mitocholine group compared to the Placebo group
Assessed by a Paired Associated Learning Task
Measured: Baseline to end of intervention (week 16)
Change in Memory outcomes (episodic memory) in the Mitocholine group compared to the Placebo group
Assessed by a Word Recall Task
Measured: Baseline to end of intervention (week 16)
Change in Language outcomes in the Mitocholine group compared to the Placebo group
Assessed by the Boston Naming Test (spontaneous responses and total correct responses)
Measured: Baseline to end of intervention (week 16)
Change in individual verbal and non-verbal Executive Function Scores in the Mitocholine group compared to the Placebo group.
Assessed by individual tests within the DKEFS battery
Measured: Baseline to end of intervention (week 16)
Evaluate the effect of consumption of Mitocholine on blood markers of insulin sensitivity
Assessed by Glucose levels
Measured: Baseline to end of intervention (week 16)
Evaluate the effect of consumption of Mitocholine on blood markers of insulin sensitivity
Assessed by insulin levels
Measured: Baseline to end of intervention (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start9 Jan 2023
- Primary completion16 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blinded, placebo-controlled, parallel proof of concept study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitocholine Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Steve Morrison, Study director, Mitocholine LtdMarie-Claire Fichot, Study director, Mitocholine Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690724
- Sponsor's protocol ID
- AFCRO-155
- Status last verified
- Aug 2025
- First submitted
- 6 Jan 2023
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel-group Study in Otherwise Healthy Adults With Mild Cognitive Impairment (MCI) Assessing a 16-week Intervention With Mitocholine™, a Functional Food Ingredient
- ClinicalTrials.gov ID
- NCT05690724
- Acronym / sponsor ID
- AFCRO-155
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mitocholine LtdIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 19 Jan 2023 (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.
To evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment. The study will also include measures of memory, language, S-adenosylmethionone (SAM), Betaine, Choline.
Detailed description
A randomised, double-blind, placebo-controlled, parallel-group study in otherwise healthy adults with Mild Cognitive Impairment (MCI).
Assessing a 16-week intervention with Mitocholine™, a functional food ingredient to evaluate the effect of 16-weeks consumption of Mitocholine on Executive Function and Homocysteine levels in a population experiencing Mild Cognitive Impairment.
The primary hypotheses being that there will be a significant change in Executive Function scores as measured by Delis Kaplan Executive Function Score (DKEFS) and in homocysteine levels.
The study will also include measures of memory, language, S-adenosylmethionone (SAM), Betaine, Choline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blinded, placebo-controlled, parallel proof of concept study
| Arm | Type | Receives |
|---|---|---|
| Mitocholine™ | Experimental | Dietary Supplement: Mitocholine™ or PlaceboMitocholine™ is a novel formulation of three nutrients choline, succinic acid, and nicotinamide (a vitamin B3) |
| Placebo | Placebo comparator | Dietary Supplement: Mitocholine™ or PlaceboThe Placebo product will be identical in appearance and taste to the investigational product |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing to participate in the study and comply with its procedures.
- Able to give written informed consent.
- Adults aged 55 to 79 years, inclusive.
- Meet MCI criteria, based on the Peterson criteria (Peterson et al., 1999):
- Have a homocysteine level ≥11.0μmol/L (Smith D et al, 2018).
Key exclusion criteria (18 listed)
- Diagnosis of a major cognitive disorder (e.g. Alzheimer's or Parkinson's disease diagnoses; additionally, confirmation of a mini stroke (TIA) within the last 3 months would be an exclusionary condition).
- Participants who are pregnant or wish to become pregnant during the trial.
- Participants who are lactating and/or currently breastfeeding.
- Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator.
- Participants with active or a history of alcohol or substance abuse; (exclude elevated Gamma GT \& clinically abnormal liver function test).
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 |
|---|---|---|
| Mitocholine™ or PlaceboParticipants will be instructed to consume one bottle of study product daily for the duration of the trial (16 weeks). They will be instructed to consume the product in the morning with breakfast. | Dietary supplement | Mitocholine™, Placebo |
Primary outcome
Absolute change in Executive Function Score in the Mitocholine group compared to the Placebo group.
Time frame: Baseline to end of intervention (week 16)
Assessed by the verbal fluency, colour-word interference and trail making tests in the Delis-Kaplan Executive Function System (Composite Score)
Absolute change in Homocysteine levels in the Mitocholine group compared to the Placebo group.
Time frame: Baseline to end of intervention (week 16)
Assessed by serum Homocysteine levels (umol/L)
9 secondary outcomes
Change in Choline levels in the Mitocholine group compared to the Placebo group
Time frame: Baseline to end of intervention (week 16)
Change in S-adenosylmethionone (SAM) levels in the Mitocholine group compared to the Placebo group
Time frame: Baseline to end of intervention (week 16)
Change in Betaine levels in the Mitocholine group compared to the Placebo group
Time frame: Baseline to end of intervention (week 16)
Change in Memory outcomes (visual memory) in the Mitocholine group compared to the Placebo group
Time frame: Baseline to end of intervention (week 16)
Change in Memory outcomes (episodic memory) in the Mitocholine group compared to the Placebo group
Time frame: Baseline to end of intervention (week 16)
Change in Language outcomes in the Mitocholine group compared to the Placebo group
Time frame: Baseline to end of intervention (week 16)
Change in individual verbal and non-verbal Executive Function Scores in the Mitocholine group compared to the Placebo group.
Time frame: Baseline to end of intervention (week 16)
Evaluate the effect of consumption of Mitocholine on blood markers of insulin sensitivity
Time frame: Baseline to end of intervention (week 16)
Evaluate the effect of consumption of Mitocholine on blood markers of insulin sensitivity
Time frame: Baseline to end of intervention (week 16)
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 18 Aug 2026.
- 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.
Steve Morrison study director
Mitocholine Ltd
Marie-Claire Fichot study director
Mitocholine Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Mild Cognitive Impairment, run by Mitocholine Ltd at 1 site in Ireland.
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 10 inclusion and 18 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 18 Aug 2026. 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 Ireland. 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?
Absolute change in Executive Function Score in the Mitocholine group compared to the Placebo group. (time frame: Baseline to end of intervention (week 16)). 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 18 Aug 2026.