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
- Diseases
- Alzheimer disease
- 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
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cognitive Neurology Center - Lariboisière Fernand Widal University Hospital (APHP) | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.