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Mild Cognitive ImpairmentNCT06347315

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)

A study testing BrainXpert in people with Mild Cognitive Impairment, run by Société des Produits Nestlé (SPN) at 28 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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) Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment
What is being tested?
BrainXpert
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
28 sitesin 6 countries
Study dates
24 May 2024to 15 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 20Show fewer
  • 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).
  • CDR global score of 0 to 0.5 at screening.
  • Sexually active females of childbearing potential (defined in further detail in Appendix 1 of the protocol) must practice 2 different highly effective methods of contraception with their heterosexual partner or remain abstinent during the trial and for 30 days after the last dose of nutritional formulation. If employing contraception, the highly effective methods of contraception detailed in Appendix 1 of the protocol must be followed.
  • Females of childbearing potential must have a negative highly sensitive urine pregnancy test before randomization; a positive urine pregnancy test result must immediately be confirmed using a serum test.
  • Participants able to satisfactorily comply with the protocol requirements.
  • Participants willing and able to discontinue all prohibited concomitant medications to meet any protocol-required washout periods before and during the trial period (Section 9.6.1 of the protocol provides more details).

Who cannot join

  • 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.
Show all 37Show fewer
  • 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.
  • Uncontrolled hypertension (systolic blood pressure >160 mm Hg, and/or diastolic blood pressure >100 mm Hg).
  • Significant and uncontrolled thyroid disease according to the investigator's judgment.
  • Any surgery or procedure requiring general anesthesia ≥3 hours, planned, or in the previous 3 months.
  • Poorly regulated type 2 diabetes (HbA1c >9.0%), or type 2 diabetes that is currently treated with insulin, glucagon-like peptide-1 receptor analog (GLP-1 RA), or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, or type 1 diabetes.
  • Vitamin B12 deficiency per the investigator's judgment, or current use of B-vitamin supplementation >200% daily recommended value according to national standards.
  • Very high or severe hypertriglyceridemia (≥886 mg/dL or 10.0 mmol/L).
  • Participants who are unable to comply with protocol procedures in the opinion of the investigator (if an individual develops a major neurocognitive disorder during the course of the trial, the appropriateness for the individual to continue will be based on the investigator's judgment).
  • Have a personal or hierarchical link with the research team members.
  • Participant who is a shift worker that involves night shifts.
  • Ongoing/planned pregnancy or breastfeeding at screening (female participants who have a positive pregnancy test result before receiving nutritional formulation will be excluded).
  • Participants who follow a ketogenic diet or other diet that is intended to influence ketone levels (eg, prolonged fasting, intermittent fasting, ketogenic meal replacement product regimens), or take ketone-, kMCT-, or coconut oil supplementation, or adhere to a diet that excludes milk product use (eg, vegan diet).
  • Cow's milk protein allergy or intolerance, or other allergy or intolerance to any of the ingredients of the nutritional formulation (eg, medium chain acyl-CoA deficiency, or other fatty acid oxidation disorders).
  • US protocol specificities:
  • 4. Have 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, as aligned with the National Institute on Aging and the Alzheimer's Association or Mayo Clinic standards for MCI, 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 (CERADNB):
  • 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.
  • 6. Participants must have an available trial informant willing to attend the following 4 clinic visits with the participant: screening, V1/randomization, V3/12-month visit, and V4/18-month visit.
  • 9. CDR global score of 0 at screening.
  • 10. Sexually active females of childbearing potential must practice highly effective methods of contraception with their heterosexual partner (defined in further detail in Appendix 1 of the protocol) or remain abstinent during the trial and for 30 days after the last dose of nutritional formulation. If employing contraception, the highly effective methods of contraception detailed in Appendix 1 of the protocol must be followed.

Trial locations and contacts

28 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Liljana Claret-Tournier contact

+41 21 924 9825

liljana.claret-tournier@rd.nestle.com

28 sites in 6 countries

Italy8 sites, 8 recruiting

  • Foundation Institute G.Giglio

    Cefalù

    Luigi Grimaldi, MD

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova

    Matteo Pardini, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

    Palermo

    Mario Barbagallo, MD

    Recruiting

  • AOU Policlinico Umberto I - Sapienza Università di Roma

    Roma

    Giuseppe Bruno, MD

    Recruiting

  • Azienda Ospedaliera SantAndrea

    Roma

    Franco Giubilei, MD

    Recruiting

  • Laboratory of Neuropsyichiatry, Fondazione Santa Lucia IRCCS

    Roma

    Clelia Pellicano, MD

    Recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma

    Camillo Marra, MD

    Recruiting

  • AO Card. G. Panico

    Tricase

    Daniele Urso, MD

    Recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Hospital Universitario del Vinalopó

    Alicante

    Ana López García, MD

    Recruiting

  • Fundaciò ACE

    Barcelona

    Merce Boada Rovira, MD

    Recruiting

  • HGU Gregorio Marañón

    Madrid

    Javier Olazarán, MD

    Recruiting

  • Unidad de Investigación Neurociencias Centro de Salud San Juan

    Salamanca

    Angel Luis Montejo Gonzalez, MD

    Recruiting

  • Hospital Universitari General de Catalunya

    Sant Cugat del Vallès

    Ernest Balaguer Martinez, MD

    Recruiting

  • Hospital Universitario Victoria Eugenia

    Seville

    Felix Vinuela Fernandez, MD

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia

    Miguel Baquero, MD

    Recruiting

Other trials in Spain

France4 sites, 4 recruiting

  • Hôpital Pierre Wertheimer

    Bron

    Helene Mollion, MD

    Recruiting

  • CHU de Montpellier - Hôpital Gui de Chauliac

    Montpellier

    Karim Bennys, MD

    Recruiting

  • CHU de Nantes - Hôpital Nord Laennec

    Nantes

    Claire Boutoleau-Bretonniere, MD

    Recruiting

  • CHU de Toulouse - Gerontopole

    Toulouse

    Pierre Jean Ousset, MD

    Recruiting

Other trials in France

Germany4 sites, 4 recruiting

  • Klinikum Bayreuth GmbH - Klinik Hohe Warte

    Bayreuth

    Patrick Oschmann, MD

    Recruiting

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen

    Felix Bischof, MD

    Recruiting

  • Neuro Centrum Science GmbH

    Erbach im Odenwald

    Gerd Reifschneider, MD

    Recruiting

  • Universitaetsmedizin Ulm

    Ulm

    Doerte Polivka, MD

    Recruiting

Other trials in Germany

Switzerland3 sites, 3 recruiting

  • Universitare Altersmedizin FELIX PLATTER

    Basel, Basel, 4055

    Sabine Dr. Krumm, +41613264767, sabine.krumm@felixplatter.ch

    Recruiting

  • Spitalzentrum Centre Hospitalier Biel-Bienne AG (SZB)

    Biel

    Hans-Albert Pihan, MD

    Recruiting

  • CHUV

    Lausanne

    Olivier Rouaud, MD

    Recruiting

Other trials in Switzerland

United Kingdom2 sites, 2 recruiting

  • Sussex Partnership NHS foundation Trust

    Crowborough

    Naji Tabet, MD

    Recruiting

  • Hampshire & Isle of Wight Healthcare NHS Foundation Trust

    Southampton

    Brady McFarlane, MD

    Recruiting

Other trials in United Kingdom

About this study

Official title: COGNIKET-MCI Trial: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center, Multi-country, Pivotal Trial to Study the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides (kMCT) and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment

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)

Being tested
BrainXpert, 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.

  • BrainXpertDietary supplement

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

  • PlaceboOther

    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.

Study groups in NCT06347315
Study groupRoleWhat they receive
BrainXpertActive comparator15 g kMCT + B-vitamins (B3, B6, B9/folic acid, and B12) will be provided in powder format
Receives: Dietary Supplement: BrainXpert
PlaceboPlacebo comparatorhigh-oleic acid sunflower oil as a calorie-equivalent, non-ketogenic vegetable oil, non added vitamin product will be provided in a powder format .
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (6)

  1. 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]).

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. 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])

    Measured: 12 months

  5. Mini-Mental State Examination (MMSE) score accelerated decline

    Percentage of participants achieving accelerated cognitive decline, defined as a change from baseline in the Mini-Mental State Examination (MMSE) total score of <24 or a decline of >3 points Scale range 0 to 30 - higher score indicates better performance

    Measured: 12 months

  6. Emergent Adverse Events (Safety and tolerability)

    Adverse events (AEs), including gastrointestinal tolerability and nausea, vital signs, changes in blood biomarkers (hematology, liver, kidney) over the course of the trial

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study start24 May 2024
  3. Primary completion15 Dec 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

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
parallel and pivotal
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06347315
Sponsor's protocol ID
2302.CLI
Status last verified
Jun 2026
First submitted
28 Mar 2024
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing BrainXpert in people with Mild Cognitive Impairment, run by Société des Produits Nestlé (SPN) at 28 sites in 6 countries.

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 20 inclusion and 37 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Italy, Spain, France, Germany, Switzerland and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Liljana Claret-Tournier (+41 21 924 9825, liljana.claret-tournier@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Preclinical Alzheimer's Cognitive Composite (PACC) score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06347315.

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 Jun 2026.

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