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Search / Trial NCT04701957

The Ketogenic Diet for Alzheimer's Disease

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 7, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of the ketogenic diet (KD) on people with early Alzheimer's disease (AD). The ketogenic diet is a special way of eating that focuses on high-fat, low-carbohydrate foods, which can help the brain use fat for energy instead of sugar. Researchers believe this diet might improve brain function, reduce inflammation, and enhance overall well-being in individuals with Alzheimer's. The study will involve 70 participants who will follow the ketogenic diet for one year, and their brain activity will be monitored using PET scans. They will also check how the diet affects memory, daily life, and quality of life.

To be eligible for the trial, participants should be at least 50 years old, have a confirmed diagnosis of Alzheimer's (using specific brain scans or tests), and be able to speak and understand French. It's important for participants to have a caregiver to support them during the study. People with certain conditions, like diabetes or other serious illnesses, would not be able to participate. Throughout the study, researchers will also look at how safe the diet is and whether participants can stick to it. If you or someone you know is interested, this could be an exciting opportunity to explore a new approach to managing Alzheimer's disease.

Gender

ALL

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

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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