Actively Recruiting
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)
Led by Société des Produits Nestlé (SPN) · Updated on 2025-08-14
380
Participants Needed
30
Research Sites
185 weeks
Total Duration
On this page
Sponsors
S
Société des Produits Nestlé (SPN)
Lead Sponsor
S
Syneos Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Eligibility Criteria
You may qualify if you...
- Have read, understood, and signed the informed consent form
- Be aged 60 years or older at the time of screening
- Have acquired memory or cognitive complaints lasting more than 3 months, reported by the participant or a trial informant
- Clinical diagnosis of mild cognitive impairment (MCI) consistent with Alzheimer's disease, insidious small vessel disease, or mixed AD/SVD, supported by at least one objective cognitive test criterion from the Consortium to Establish a Registry for Alzheimer's Disease neuropsychological battery (CERAD NB)
- Full autonomy for daily living based on the Instrumental Activities of Daily Living (IADL)-Lawton scale (score of 8 for women or 5 for men)
- Have a trial informant available and willing to attend clinic visits at randomization, 12 months, and 18 months
- Trial informant has sufficient contact with the participant (at least 2 hours per day, minimum 4 times per week)
- Adequate ability to read, write, and sufficient vision and hearing for neuropsychological testing
- Clinical Dementia Rating (CDR) global score of 0 to 0.5 at screening
- Sexually active females of childbearing potential must use two highly effective contraception methods with their heterosexual partner or remain abstinent during the trial and for 30 days after last dose
- Females of childbearing potential must have a negative highly sensitive urine pregnancy test before randomization
- Able to comply with protocol requirements
- Willing and able to discontinue prohibited medications before and during the trial
You will not qualify if you...
- Diagnosis of major neurocognitive disorder or dementia at enrollment
- MCI due to concussion, COVID-19, or specific other causes including neurodegenerative diseases like Parkinson's, multiple sclerosis, Huntington's, Lewy-body disease, frontotemporal dementia, or medication/substance use
- COVID-19 infection within 120 days before screening or vaccination against SARS-CoV-2 within 14 days before screening
- Recent changes in medications affecting cognition or Alzheimer's disease treatments within 2 months before randomization
- Likely need for prohibited therapy during trial
- History of alcohol or substance use disorder interfering with participation
- Investigator or sponsor judgment against participation
- Symptoms of depression or anxiety based on Hospital Anxiety and Depression Scale
- Known active HIV, COVID, hepatitis B or C infection
- History of epilepsy or seizures except certain childhood or withdrawal seizures
- Poor general health or recent significant illness or weight loss
- Cancer diagnosis within past 2 years excluding some skin cancers or early-stage cancers with good prognosis
- Severe renal disease (eGFR <30 ml/min/1.73m2)
- Uncontrolled hypertension (systolic >160 mm Hg or diastolic >100 mm Hg)
- Significant uncontrolled thyroid disease
- Recent or planned surgery with general anesthesia over 3 hours
- Poorly regulated type 2 diabetes or insulin/GLP-1 RA/SGLT-2 treated diabetes or type 1 diabetes
- Vitamin B12 deficiency or high-dose B-vitamin supplementation
- Very high triglycerides (≥886 mg/dL)
- Inability to comply with study procedures
- Personal or hierarchical relationship with research team
- Shift work involving night shifts
- Pregnancy or breastfeeding
- Following ketogenic or similar diets or taking related supplements
- Allergy or intolerance to milk products or study ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Stein Gerontological Institute Inc
Miami, Florida, United States, 33137
Not Yet Recruiting
2
University of Rochester
Rochester, New York, United States, 14620
Not Yet Recruiting
3
Hôpital Pierre Wertheimer
Bron, France
Actively Recruiting
4
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, France
Actively Recruiting
5
CHU de Nantes - Hôpital Nord Laennec
Nantes, France
Actively Recruiting
6
CHU de Toulouse - Gerontopole
Toulouse, France
Actively Recruiting
7
Klinikum Bayreuth GmbH - Klinik Hohe Warte
Bayreuth, Germany
Actively Recruiting
8
Studienzentrum für Neurologie und Psychiatrie
Böblingen, Germany
Actively Recruiting
9
Neuro Centrum Science GmbH
Erbach im Odenwald, Germany
Actively Recruiting
10
Universitaetsmedizin Ulm
Ulm, Germany
Actively Recruiting
11
Foundation Institute G.Giglio
Cefalù, Italy
Actively Recruiting
12
IRCCS Ospedale Policlinico San Martino
Genova, Italy
Actively Recruiting
13
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, Italy
Actively Recruiting
14
AOU Policlinico Umberto I - Sapienza Università di Roma
Roma, Italy
Actively Recruiting
15
Azienda Ospedaliera SantAndrea
Roma, Italy
Actively Recruiting
16
Laboratory of Neuropsyichiatry, Fondazione Santa Lucia IRCCS
Roma, Italy
Actively Recruiting
17
Policlinico Universitario Agostino Gemelli
Roma, Italy
Actively Recruiting
18
AO Card. G. Panico
Tricase, Italy
Actively Recruiting
19
Hospital Universitario del Vinalopó
Alicante, Spain
Actively Recruiting
20
Fundaciò ACE
Barcelona, Spain
Actively Recruiting
21
HGU Gregorio Marañón
Madrid, Spain
Actively Recruiting
22
Unidad de Investigación Neurociencias Centro de Salud San Juan
Salamanca, Spain
Actively Recruiting
23
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Spain
Actively Recruiting
24
Hospital Universitario Victoria Eugenia
Seville, Spain
Actively Recruiting
25
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Actively Recruiting
26
Universitare Altersmedizin FELIX PLATTER
Basel, Switzerland, 4055
Not Yet Recruiting
27
Spitalzentrum Centre Hospitalier Biel-Bienne AG (SZB)
Biel, Switzerland
Actively Recruiting
28
CHUV
Lausanne, Switzerland
Actively Recruiting
29
Sussex Partnership NHS foundation Trust
Crowborough, United Kingdom
Actively Recruiting
30
Hampshire & Isle of Wight Healthcare NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
Research Team
M
Monique Bunyan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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