Evaluating Mitocholine for Mild Cognitive Impairment in Adults

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

This study is testing if a special ingredient called Mitocholine can help improve memory and thinking skills in adults aged 55 to 79 who have mild cognitive impairment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 55 Years to 79 Years
• Sex: All
• Sponsor: Mitocholine Ltd (Industry-sponsored)
• Locations: 1 site (Cork, Munster)
• Trial ID: NCT05690724 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of a 16-week intervention using Mitocholine™, a functional food ingredient, on executive function and homocysteine levels in adults aged 55 to 79 with mild cognitive impairment (MCI). Participants will be assessed for cognitive impairment using the MoCA test and will either receive Mitocholine or a placebo. The study aims to measure improvements in memory, language, and other cognitive functions, as well as changes in biochemical markers related to cognitive health.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 55 to 79 who meet the criteria for mild cognitive impairment and have elevated homocysteine levels.

Not a fit: Patients with major cognitive disorders such as Alzheimer's or Parkinson's disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could improve cognitive function and overall brain health in individuals with mild cognitive impairment.

How similar studies have performed: While there is ongoing research into functional food ingredients for cognitive health, the specific use of Mitocholine in this context is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Willing to participate in the study and comply with its procedures.
2. Able to give written informed consent.
3. Adults aged 55 to 79 years, inclusive.
4. Meet MCI criteria, based on the Peterson criteria (Peterson et al., 1999):

   1. Objective evidence of cognitive impairment as assessed by MoCA (score ≥18 to ≤25).
   2. Absence of major depression as assessed by PHQ (score \<10).
   3. Activities of daily living score

      * males ≥4
      * females ≥7
5. Have a homocysteine level ≥11.0μmol/L (Smith D et al, 2018).

Exclusion Criteria:

1. 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).
2. Participants who are pregnant or wish to become pregnant during the trial.
3. Participants who are lactating and/or currently breastfeeding.
4. Participants currently of childbearing potential, but not using an effective method of contraception, as determined by the investigator.
5. Participants with active or a history of alcohol or substance abuse; (exclude elevated Gamma GT \& clinically abnormal liver function test).
6. Uncontrolled diabetes (or glycated haemoglobin \>7% / 53 mmol/mol).
7. Clinically significant heart, liver, or renal disease (at the discretion of the investigator).
8. Have uncontrolled hypertension SBP \> 160mmHg, DBP \> 100mmHg).
9. Participants prescribed medications likely to influence memory or mood, as determined by the investigator.
10. 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
11. 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.
12. Change in supplements, medication, or major diet in 30 days prior to enrolment and throughout the study.
13. 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.
14. 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.
15. Has received treatment involving experimental drugs in the past 3 months.
16. Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study.
17. 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.
18. 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.

Where this trial is running

Cork, Munster

• Atlantia Clinical Trials — Cork, Munster, Ireland (Recruiting)

Study contacts

• Study coordinator: Eile Butler

Conditions Mild Cognitive Impairment