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The Ketogenic Diet for Alzheimer's Disease

Study acronym: CETOMA
StatusTerminated
PhaseNot applicable
Started2023-03-30
View on ClinicalTrials.gov ↗

Amendment history

2026-09-07
critical
Active, Not Recruiting→Terminated Study Status v9
Trial terminated: lake of inclusions
Trial statusActive, Not Recruiting→Terminated
Primary completion dateestimated 2026-09→confirmed 2026-09-03
Completion dateestimated 2026-09→confirmed 2026-09-03
2026-03-31
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v8
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2027-03→2026-09
Completion date2027-03→2026-09
Enrollment targetestimated 70→confirmed 17
Study sitesdetails revised at 1 of 1 site
2025-11-17
minor
2 amendments v6-v7
2 re-verifications since 2025-06-19, no change to tracked fields
2024-05-06
minor
Study Status, Eligibility v5
Primary completion date2025-03→2027-03
Completion date2025-03→2027-03
Eligibility criteria+23 characters
Inclusion Criteria: Age >= 50 AD confirmed by biomarkers (CSF biomarkersand/or PET scan) CDR score=0.5 or 1 Speaking/understanding French Presence of a caregiver Exclu [...]
2023-03-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-01→2025-03
Completion date2025-01→2025-03
Start dateestimated 2023-01→confirmed 2023-03-30
Study sitesdetails revised at 1 of 1 site
Show 3 earlier versions
2022-12-07
minor
Study Status v3
Primary completion date2024-09→2025-01
Completion date2024-09→2025-01
Start date2022-09→2023-01
2022-08-29
minor
Study Status v2
Primary completion date2024-02→2024-09
Completion date2024-02→2024-09
Start date2022-02→2022-09
2021-11-22
minor
Study Status, Study Description, Outcome Measures v1
Primary completion date2022-02→2024-02
Completion date2023-02→2024-02
Start date2021-02→2022-02
Secondary endpointsdetails revised at 3 of 6 entries
Study description+7 characters
[...] etitian consultations in both groups (day 1, day 15, month 1, month 3, month 5, month 9) All the visits comprise: ketosis measu [...]
2021-01-07
minor
Original filing
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.
Trial Details
NCT Number NCT04701957
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: France Alzheimer
Conditions Alzheimer Disease, Early Onset
Enrollment 17 participants
Start Date 2023-03-30
Primary Completion 2026-09-03 (estimated)
Study Completion 2026-09-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-10