Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides a… (NCT06347315) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
France, Germany, Italy380 participantsStarted 2024-05-24
Plain-language summary
Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Have read, understood, and signed the informed consent form (ICF).
. Be aged ≥60 years at the time of screening.
. Presence of acquired memory complaints with a duration of \>3 months. Here we refer to memory/cognitive complaints in a broader sense that can involve other cognitive domains other than memory. (As reported by the participant or reliable trial informant. Trial informants can be a relative, spouse or domestic partner, or close friend who interacts closely enough with the participant to be able to respond to assessments/questionnaires as needed.)
. Have a clinical diagnosis of MCI (with a clinical phenotype compatible with AD, insidious SVD \[ie, no post-stroke cognitive impairment\], or mixed AD/SVD) according to the participating site, or referring center, aligned with international/national standards for MCI diagnosis, and additionally informed by a minimum of one of the following objective criteria as assessed by components of the Consortium to Establish a Registry for Alzheimer's Disease neuropsychological battery (CERAD NB):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial uses a nutritional intervention — ketogenic medium-chain triglycerides and B-vitamins rather than a drug — what does my doctor think about whether this type of approach is appropriate for my current stage of mild cognitive impairment?
2The trial is measuring something called the Preclinical Alzheimer's Cognitive Composite (PACC) score — can my doctor explain what that test involves and whether my current cognitive testing results would give us a useful baseline to compare against?
3Because this is listed as Phase NA, meaning it's a nutritional study rather than a standard drug trial, does my doctor have any concerns about the safety of a ketogenic MCT supplement for someone with my specific health history, including any heart, liver, or digestive conditions?
4Are there standard-of-care treatments or lifestyle interventions for mild cognitive impairment that my doctor would recommend I consider first, or alongside this trial, rather than relying on this nutritional study alone?
5What would participating in this trial actually look like day-to-day — how often would I need to come in, how long does the study last, and how would my doctor stay involved in monitoring my cognitive health while I'm enrolled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Fifteen-item subset of the Boston Naming Test (BNT): ≤13,
. Constructional praxis recall: ≤7, or
Exclusion criteria
. Diagnosis of a major neurocognitive disorder according to the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), or dementia according to the DSM-IV and the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association criteria at the time of enrollment.
. MCI related to past or recent concussion, COVID-19, or other specific etiologies (including neurodegenerative disease like Parkinson's disease, multiple sclerosis, Huntington's disease, Lewy-body disease, fronto temporal dementia), or associated with medication/substance use, per the investigator's judgment.
. A history of COVID-19 ≤120 days before screening or completion of a vaccination course against severe acute respiratory syndrome coronavirus 2 ≤14 days before screening. The vaccine received must have been authorized for emergency use or approved by the US Food and Drug Administration.
. Newly introduced, or change in dose, within the last 2 months before randomization, of physician-prescribed interventions or medications affecting cognition or AD (eg, acetylcholinesterase inhibitors, memantine, anti-amyloid-beta agents), or planned introduction of such medications during the trial.
. Participants who will likely require prohibited concomitant therapy during the trial based on the investigator's judgment.
. Known history of or ongoing alcohol or substance use disorder, based on medical history, that in the opinion of the investigator may conflict with the participant's participation.
. Participants who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.
. Symptoms suggestive of depression or anxiety according to the Hospital Anxiety and Depression Scale (HADS):