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)
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.)
Word list memory task: ≤19,
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.
Parallel
BrainXpert
Dietary supplementsachet/stickpack of 25 g, has no preservatives, no flavors, no sweeteners, and no colorants.
Placebo
Other interventionhigh-oleic acid sunflower oil as a calorie-equivalent, non-ketogenic vegetable oil, non added vitamin product will also be provided in a powder format in a sachet/stickpack of 25 g.
Preclinical Alzheimer's Cognitive Composite (PACC) score
The change from baseline on the PACC composite cognitive score of episodic memory, timed executive function, and global cognition PACC has 4 components: * Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); * Logical Memory Ib (Immediate Recall) from the WMS-IV (Range 0 (worst)-25 (best recall); * Wechsler Adult Intelligence scale - revised: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-93 \[best performance\]) * Mini Mental State Examination (Range 0 \[worst\] - 30 \[best performance\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.
Preclinical Alzheimer's Cognitive Composite (PACC) (components effects)
Individual interventional effects on change from baseline in the individual components of the PACC test (cognitive domains of executive function, episodic memory, and global cognitive function) PACC has 4 components: * Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); * Logical Memory Ib (Immediate Recall) from the WMS-IV (Range 0 (worst)-25 (best recall); * Wechsler Adult Intelligence scale - revised: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-93 \[best performance\]) * Mini Mental State Examination (Range 0 \[worst\] - 30 \[best performance\]).
Montreal Cognitive Assessment (MoCA) score
The change from baseline in the Montreal Cognitive Assessment (MoCA) total score Scale range 0 to 30 - higher score indicates better performance
Preclinical Alzheimer's Cognitive Composite (PACC) accelerated decline
Percentage of participants achieving accelerated cognitive decline, defined as a change from baseline in the PACC z-score of at least 1 SD below the mean PACC has 4 components: * Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); * Logical Memory Ib (Immediate Recall) from the WMS-IV (Range 0 (worst)-25 (best recall); * Wechsler Adult Intelligence scale - revised: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-93 \[best performance\]) * Mini Mental State Examination (Range 0 \[worst\] - 30 \[best performance\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.
Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory IIb Delayed Recall Score accelerated decline
Percentage of participants achieving accelerated memory decline, defined as a change from baseline in episodic memory (\>3 points) as assessed by the "WMS-IV Logical Memory IIb Delayed Recall Score" Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \[none\]-91 \[best performance\])
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Société des Produits Nestlé (SPN)
Lead sponsor
Syneos Health
Collaborator
