The Ketogenic Diet for Alzheimer's Disease: a Randomized Controlled Feasibility Study.
Ketogenic Diet Explored for Early Alzheimer's Disease
Plain English Summary
The Ketogenic Diet for Alzheimer's Disease is a Not Applicable clinical trial sponsored by Assistance Publique - Hôpitaux de Paris studying Alzheimer Disease, Early Onset. This study tests if a ketogenic diet is a feasible and safe approach for people with early Alzheimer's disease. It is for individuals aged 50 and older diagnosed with early Alzheimer's disease who can speak and understand French. Participants will follow either a ketogenic diet or a control diet for one year, with regular monitoring. Currently, there are no standard dietary interventions proven to treat Alzheimer's disease. The trial aims to enroll 17 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 50 or older and have confirmed early Alzheimer's disease. You must be able to speak and understand French and have a caregiver to help you. You cannot join if you have diabetes, other neurological diseases, or certain inflammatory conditions. Individuals with malnutrition or severe chronic health problems are also excluded. This trial is studying Alzheimer Disease, Early Onset, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures the feasibility of the ketogenic diet, meaning how well participants can stick to it over 12 months, indicated by urinary ketone levels. The specific primary outcome measures are: Feasibilty of Ketogenic diet with urinary ketone levels (12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial explores a ketogenic diet as a potential alternative fuel source for the brain, aiming to address the decline in glucose utilization seen in early Alzheimer's disease. This research targets Alzheimer Disease, Early Onset, where improved treatment options are needed.
Investor Insight
This study investigates a novel dietary intervention for a significant unmet need in Alzheimer's disease, with potential implications for a large and growing market if proven effective and safe.
Is This Trial Right for Me?
Ask your doctor if a ketogenic diet is appropriate for you, considering your overall health and any existing conditions. Participation involves following a specific diet plan for one year, which may include regular check-ups and tests. The ketogenic diet involves significantly reducing carbohydrate intake while increasing fat intake, which requires careful planning and monitoring. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 17 participants
Interventions
- BEHAVIORAL: Ketogenic diet — The Atkins 2: 1 diet as prescribed for the participants of our intervention group (N = 35) is based on a diet moderately rich in protein (meat, fish, cheese, eggs, vegetable proteins) and without restriction of fats, provided they are balanced, but limiting the carbohydrate intake (bread, pasta, rice) to 50 grams / day. The ratio calories from fat / calories from protein + carbohydrates will be 3 to 1
Primary Outcomes
- Feasibilty of Ketogenic diet with urinary ketone levels (12 months)
Secondary Outcomes
- Efficiency of ketogenic diet on cognition (12 months)
- Safety of ketogenic diet with weight (12 months)
- Safety of ketogenic diet with albumin levels (12 months)
- Safety of ketogenic diet with lipid levels (12 months)
- Efficiency of ketogenic diet on brain metabolism (12 months)
Full Eligibility Criteria
Inclusion Criteria: * Age \>= 50 * AD confirmed by biomarkers (CSF and/or PET scan) * CDR score=0.5 or 1 * Speaking/understanding French * Presence of a caregiver Exclusion Criteria: * Diabetes * Other neurological disease * Chronic inflammatory disease or anti-inflammatory medication (e.g. NSAI, corticosteroids) * Uncontrolled dyslipidemia * Malnutrition (BMI \< 18; or weight loss \> 5% in 1 month or 10% in 6 months; or MNA \< 17) * Severe chronic condition or organ dysfunction
Trial Locations
- Cognitive Neurology Center - Lariboisière Fernand Widal University Hospital (APHP), Paris, France
Frequently Asked Questions
What is clinical trial NCT04701957?
NCT04701957 is a Not Applicable INTERVENTIONAL study titled "The Ketogenic Diet for Alzheimer's Disease." It is currently active, not recruiting and is sponsored by Assistance Publique - Hôpitaux de Paris. The trial targets enrollment of 17 participants.
What conditions does NCT04701957 study?
This trial investigates treatments for Alzheimer Disease, Early Onset. The primary condition under study is Alzheimer Disease, Early Onset.
What treatments are being tested in NCT04701957?
The interventions being studied include: Ketogenic diet (BEHAVIORAL). The Atkins 2: 1 diet as prescribed for the participants of our intervention group (N = 35) is based on a diet moderately rich in protein (meat, fish, cheese, eggs, vegetable proteins) and without restriction of fats, provided they are balanced, but limiting the carbohydrate intake (bread, pasta, rice) to 50 grams / day. The ratio calories from fat / calories from protein + carbohydrates will be 3 to 1
What does Not Applicable mean for NCT04701957?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04701957?
This trial is currently "Active, Not Recruiting." It started on 2023-03-30. The estimated completion date is 2026-09.
Who is sponsoring NCT04701957?
NCT04701957 is sponsored by Assistance Publique - Hôpitaux de Paris. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04701957?
The trial aims to enroll 17 participants. The trial status is active, not recruiting.
How is NCT04701957 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT04701957?
The primary outcome measures are: Feasibilty of Ketogenic diet with urinary ketone levels (12 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04701957 being conducted?
This trial is being conducted at 1 site, including Paris (France).
Where can I find official information about NCT04701957?
The official record for NCT04701957 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04701957. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04701957 testing in simple terms?
This study tests if a ketogenic diet is a feasible and safe approach for people with early Alzheimer's disease. It is for individuals aged 50 and older diagnosed with early Alzheimer's disease who can speak and understand French.
Why is this trial significant?
This trial explores a ketogenic diet as a potential alternative fuel source for the brain, aiming to address the decline in glucose utilization seen in early Alzheimer's disease.
What are the potential risks of participating in NCT04701957?
Potential side effects of a ketogenic diet can include fatigue, constipation, and changes in cholesterol levels. Close monitoring is necessary to ensure nutritional balance and manage any adverse effects. Adherence to the diet can be challenging and may require significant lifestyle adjustments. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04701957?
Ask your doctor if a ketogenic diet is appropriate for you, considering your overall health and any existing conditions. Participation involves following a specific diet plan for one year, which may include regular check-ups and tests. The ketogenic diet involves significantly reducing carbohydrate intake while increasing fat intake, which requires careful planning and monitoring. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04701957 signal from an investment perspective?
This study investigates a novel dietary intervention for a significant unmet need in Alzheimer's disease, with potential implications for a large and growing market if proven effective and safe. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will follow either a ketogenic diet or a control diet for one year, with regular monitoring. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Alzheimer Disease, Early Onset Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.