NCT06681948

The Ketogenic Diet in the Treatment of Alzheimer's Disease

A Randomized, Double-Blind, Placebo Parallel-Controlled, Multicenter Clinical Study for Evaluating the Efficacy, Safety and Tolerability of JT821 in the Treatment of Mild and Moderate Alzheimer's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This research is a randomized, double-blind, placebo-parallel controlled, and multi-center clinical study in China, aiming to evaluate the tolerability, efficacy, and safety of JT821 (Ketogenic Diet) in the treatment of mild to moderate Alzheimer's disease. The ketogenic diet (KD) is a low-carbohydrate, adequate protein and high-fat diet. KD was shown to be effective in treating different neurodegenerative diseases.

Detailed description

This is a randomized, double-blind, placebo-controlled, multi-center clinical study planned to include 300 subjects diagnosed with mild to moderate Alzheimer's disease. The primary aim of the study is to evaluate the tolerability, efficacy, and safety of JT821 in the treatment of mild to moderate Alzheimer's disease. Eligible patients will be randomly assigned in a 1:1 ratio to either the JT821 group or the placebo group. All subjects will undergo a 2-week product titration period based on a stable and regular anti-dementia drug treatment before entering a 26 week treatment period. Efficacy assessments will be conducted at week 13 and week 26 during the treatment period, utilizing the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and the Mini-Mental State Examination (MMSE) to assesses the overall cognitive function of the subjects. Additionally, the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) will evaluate daily living abilities; and the Quality of Life in Alzheimer's Disease (QOL-AD) will assess the quality of life of Alzheimer's disease patients. Safety evaluation will include the vital signs, laboratory tests (twelve-lead electrocardiogram, fasting blood glucose, blood ketone levels (β-hydroxybutyrate), urinalysis, complete blood count, fasting lipid profile, liver and kidney function), as well as the recording of any adverse events. Subjects may withdraw from the study at any time. If subjects experience a serious adverse event, become pregnant, are lost to follow-up, show poor adherence, or if the subject or their legal guardian actively requests to withdraw or retracts informed consent, they may be withdrawn based on the investigator's determination. The sponsor reserves the right to terminate the study at any time for special reasons (such as major safety concerns, force majeure, etc.). A safety follow-up will be conducted two weeks after the termination of treatment.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketogenic diet	Ketogenic diet
DIETARY_SUPPLEMENT	placebo	placebo

Timeline

• Start date: 2024-02-23
• Primary completion: 2025-09-10
• Completion: 2025-11-11
• First posted: 2024-11-12
• Last updated: 2026-03-23

Locations

1 site across 1 country: China