Alzheimer Disease, Early Onset · Interventional Study

The Ketogenic Diet for Alzheimer's Disease

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a terminated feasibility study registration with no posted results. The planned primary outcome was adherence to a ketogenic diet (urinary ketone levels) over 12 months in early-onset Alzheimer's disease. The study enrolled 17 of 70 planned participants before termination, so the evidence base does not yet exist.

What was studied

Interventional, Randomized, Parallel, Single masking, Other purpose. Alzheimer Disease, Early Onset; age from 50 Years. Intervention: Modified Atkins 2 :1 Ketogenic diet. Compared with: Control diet — No Intervention. n = 17. 1 site: France.

Key findings

Planned enrollment: 70 participants; actual enrollment: 17 participants before termination Primary outcome measure: Feasibility of ketogenic diet with urinary ketone levels at 12 months Secondary outcomes planned: brain metabolism (PET scan), cognition, quality of life, daily living function, safety, nutritional status, and diet adherence

Safety

Secondary outcomes planned: brain metabolism (PET scan), cognition, quality of life, daily living function, safety, nutritional status, and diet adherence

Who this may help

No clinical impact can be assessed because results are not posted. The early termination and low enrollment suggest the feasibility study itself was unsuccessful. Clinicians should not interpret this as evidence that ketogenic diet is or is not beneficial in early-onset Alzheimer's disease.

Plain-language summary

This is a terminated feasibility study with 17 enrolled (not 70 planned); no results are posted in this registry record, so the evidence base is absent and the design is exploratory.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Feasibilty of Ketogenic diet with urinary ketone levels (assessed at 12 months)

DesignInterventional, Randomized, Parallel, Single masking, Other purpose

PopulationAlzheimer Disease, Early Onset; age from 50 Years

Sample size17

InterventionModified Atkins 2 :1 Ketogenic diet

ComparatorControl diet — No Intervention

Setting1 site: France

Reported figures

Quoted from the source exactly as published.

Planned sample size70

Actual enrollment17

Primary outcome measureFeasibility of ketogenic diet with urinary ketone levels, 12 months

Follow-up duration12 months

Clinical bottom line

Caveats

Results not posted in registry record; no outcome data available for analysis
Study terminated with only 24% of planned enrollment (17 of 70); reason for termination not stated
Primary outcome is feasibility, not cognitive or clinical efficacy; secondary endpoints not yet reported
Brief summary references promising preclinical and small human studies but this trial provides no new evidence to confirm or refute those findings

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm feasibility study with no concurrent control; terminated early with lower enrollment.

Directness

moderate

Addresses early-onset Alzheimer's disease directly; primary outcome is feasibility not clinical efficacy.

Consistency

insufficient

No results reported in registry record; cannot assess consistency with other evidence.

Risk of bias

insufficient

No results or methods detail provided; feasibility studies have inherent limitations without control comparison.

Sample adequacy

limited

17 participants enrolled versus 70 planned; substantial shortfall in recruitment with early termination.

Source abstract

Registry record from ClinicalTrials.gov (NCT04701957). This is a study registration, not published results. Lead sponsor: Assistance Publique - Hôpitaux de Paris. Recruitment status: TERMINATED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 17 participants (ACTUAL). Conditions: Alzheimer Disease, Early Onset. Interventions: BEHAVIORAL: Ketogenic diet. Primary outcome measures: Feasibilty of Ketogenic diet with urinary ketone levels , 12 months. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alzheimer Disease, Early OnsetNCT04701957Assistance Publique - Hôpitaux de Paris