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)

NCT06347315 | Recruiting DMC

• 1 other identifier: 2302.CLI
• Study Type: interventional
• Target: 380
• Locations: 7 countries
• Sites: 30

Brief 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)

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• Preclinical Alzheimer's Cognitive Composite (PACC) (components effects)

  12 months

• Montreal Cognitive Assessment (MoCA) score

  12 months

• Preclinical Alzheimer's Cognitive Composite (PACC) accelerated decline

  12 months

• Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory IIb Delayed Recall Score accelerated decline

  12 months

• Mini-Mental State Examination (MMSE) score accelerated decline

  12 months

Study Arms (2)

BrainXpert

ACTIVE COMPARATOR

15 g kMCT + B-vitamins (B3, B6, B9/folic acid, and B12) will be provided in powder format

Dietary Supplement: BrainXpert

Placebo

PLACEBO COMPARATOR

high-oleic acid sunflower oil as a calorie-equivalent, non-ketogenic vegetable oil, non added vitamin product will be provided in a powder format .

Other: Placebo

Interventions

BrainXpert DIETARY_SUPPLEMENT

sachet/stickpack of 25 g, has no preservatives, no flavors, no sweeteners, and no colorants.

BrainXpert

Placebo OTHER

high-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.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• Word list memory task: ≤19,
• Word list recall: ≤5,
• Fifteen-item subset of the Boston Naming Test (BNT): ≤13,
• Constructional praxis recall: ≤7, or
• Total CERAD score: ≤70.
• Full autonomy for daily living based on the Instrumental Activities of Daily Living (IADL)-Lawton scale:
• Score for women: 8 or
• Score for men: 5.
• Participants must have an available trial informant willing and able to attend the following 3 clinic visits with the participant: V1/randomization, V3/12-month visit, and V4/18-month visit.
• Participants must have a trial informant who in the opinion of the investigator, has contact with the trial participant for a sufficient number of hours per week (at least 2 hours per day and a minimum of 4 times per week).
• Participants and their trial informants have an adequate ability to read and write, as well as adequate vision and hearing for neuropsychological testing according to the investigator's judgment (corrective aids are allowed).

You may not qualify if:

• 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):
• HADS-D ≥8 or
• HADS-A ≥8.
• Known active HIV infection, COVID, hepatitis B, or hepatitis C based on medical history.
• Participants with epilepsy or a history of seizures, except for a single childhood febrile seizure, post-traumatic seizure, or alcohol withdrawal seizure.
• Participants considered to be in poor general health based on the investigator's judgment. Examples include participants who have recent clinically significant weight loss, chronic dehydration or hypovolemia, poor fluid or nutritional intake, or a recent clinically significant infection, as per the investigator's judgment.
• Cancer diagnosis in the past 2 years excluding select skin conditions considered to be fully treated (basal cell or squamous cell carcinomas of the skin) or early-stage cancer with excellent prognosis (eg, some prostate cancer conditions) according to the investigator's judgment.
• Renal disease (estimated glomerular filtration rate \<30 ml/min/1.73m2) based on the investigator's assessment and historical data.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Syneos Health: collaborator

Study Sites (30)

Stein Gerontological Institute Inc

Miami, Florida, 33137, United States

NOT YET RECRUITING

University of Rochester

Rochester, New York, 14620, United States

NOT YET RECRUITING

Hôpital Pierre Wertheimer

Bron, France

RECRUITING

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France

RECRUITING

CHU de Nantes - Hôpital Nord Laennec

Nantes, France

RECRUITING

CHU de Toulouse - Gerontopole

Toulouse, France

RECRUITING

Klinikum Bayreuth GmbH - Klinik Hohe Warte

Bayreuth, Germany

RECRUITING

Studienzentrum für Neurologie und Psychiatrie

Böblingen, Germany

RECRUITING

Neuro Centrum Science GmbH

Erbach im Odenwald, Germany

RECRUITING

Universitaetsmedizin Ulm

Ulm, Germany

RECRUITING

Foundation Institute G.Giglio

Cefalù, Italy

RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

Palermo, Italy

RECRUITING

AOU Policlinico Umberto I - Sapienza Università di Roma

Roma, Italy

RECRUITING

Azienda Ospedaliera SantAndrea

Roma, Italy

RECRUITING

Laboratory of Neuropsyichiatry, Fondazione Santa Lucia IRCCS

Roma, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Roma, Italy

RECRUITING

AO Card. G. Panico

Tricase, Italy

RECRUITING

Hospital Universitario del Vinalopó

Alicante, Spain

RECRUITING

Fundaciò ACE

Barcelona, Spain

RECRUITING

HGU Gregorio Marañón

Madrid, Spain

RECRUITING

Unidad de Investigación Neurociencias Centro de Salud San Juan

Salamanca, Spain

RECRUITING

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Spain

RECRUITING

Hospital Universitario Victoria Eugenia

Seville, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, Spain

RECRUITING

Universitare Altersmedizin FELIX PLATTER

Basel, 4055, Switzerland

NOT YET RECRUITING

Spitalzentrum Centre Hospitalier Biel-Bienne AG (SZB)

Biel, Switzerland

RECRUITING

CHUV

Lausanne, Switzerland

RECRUITING

Sussex Partnership NHS foundation Trust

Crowborough, United Kingdom

RECRUITING

Hampshire & Isle of Wight Healthcare NHS Foundation Trust

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Monique Bunyan

CONTACT

+44 7833 293 097; monique.bunyan@uk.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel and pivotal

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

ES (7); FR (4); IT (8); CH (3); DE (4); US (2); GB (2)