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NCT04701957Terminated

The Ketogenic Diet for Alzheimer's Disease

The Ketogenic Diet for Alzheimer's Disease: a Randomized Controlled Feasibility Study.

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Reason given: lake of inclusions

Brief summary (registry, in English)

The ketogenic diet (KD) is a metabolic shift, which stimulates the liver oxidation of fatty acids to produce ketone bodies. These ketone bodies represent an alternative fuel source for the brain. The benefits of KD in epilepsia have been demonstrated for decades. This diet may also provide benefits in Alzheimer's disease (AD) where neuronal glucose utilization declines from the early stage. Besides, the KD could decrease neuroinflammation, oxidative stress and enhance mitochondrial biogenesis. In murin models of AD, KD or Medium Chain Triglycerides consumption were associated with lower neuroinflammation but also with a diminution of neuropathologic features of AD (amyloid and tau lesions in the brain). Moreover, behavioural effets and improvements in memory and motor function have been highlighted. In humans, recent studies suggest cognitive benefits (memory, executive function) in AD, including in the Mild Cognitive Impairment (MCI) stage. The feasibility and the adherence to the diet proved to be correct, in small samples, in particular in MCI individuals over a short follow-up period (3 to 6 months). This study aims at examining the feasibility of a KD followed-up for one year in participants with early AD (N=70). Change in brain metabolism will be assessed using PET scan after 12 months, comparing KD with control diet. The effects on cognition, quality of life and daily living functioning will be analysed. The safety, nutritional changes and adhesion to the diet will be monitored throughout the study.

Status (registry)
Terminated
Study type
Interventional
Enrollment
17 (actual)
First submitted
15 Dec 2020
Start date
30 Mar 2023
Primary completion date
3 Sept 2026
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT04701957

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diabetes
  • Other neurological disease
  • Chronic inflammatory disease or anti-inflammatory medication (e.g. NSAI, corticosteroids)
  • Severe chronic condition or organ dysfunction

Other

  • Uncontrolled dyslipidemia
  • Malnutrition (BMI < 18; or weight loss > 5% in 1 month or 10% in 6 months; or MNA < 17)

Who the study is looking for

  • Age >= 50
  • AD confirmed by biomarkers (CSF and/or PET scan)
  • CDR score=0.5 or 1
  • Speaking/understanding French
  • Presence of a caregiver

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Cognitive Neurology Center - Lariboisière Fernand Widal University Hospital (APHP)ParisFranceUnknown status

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