NCT06761729

The Ketogenic Diet in the Treatment of Behavioral Variant Frontotemporal Dementia

An Exploratory Study for Evaluating the Efficacy, Safety and Tolerability of JT821 in the Intervention of Behavioral Variant Frontotemporal Dementia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is an exploratory clinical research on the use of JT821 (a ketogenic diet formulation) for the treatment of patients with behavioral variant frontotemporal dementia (bvFTD), aiming to evaluate the effectiveness, safety, and tolerability of JT821 in the intervention of bvFTD. 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 an exploratory clinical research planned to include 20 subjects diagnosed with behavioral variant frontotemporal dementia (bvFTD). The primary aim of the study is to evaluate the tolerability, efficacy, and safety of JT821 in the treatment of bvFTD. All subjects will undergo a 1-week product titration period before entering a 12 week treatment period. Efficacy assessments will be conducted at week 4 and week 12 during the treatment period, utilizing the Montreal Cognitive Assessment (MoCA), the Mini-Mental State Examination (MMSE), and the Clinical Dementia Rating (CDR) scale to assesses the overall cognitive function of the subjects. Additionally, the Frontal Assessment Battery (FAB) will evaluate the executive functions of the frontal lobes; the Neuropsychiatric Inventory (NPI) and the Frontal Behavioral Inventory (FBI) assess the neuropsychiatric and behavioral symptoms of patients; the Boston Naming Test (BNT) and the Verbal Fluency Test (VFT) assess language functions. Safety evaluation will include the vital signs, laboratory tests (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or if the subject or their legal guardian actively requests to withdraw or retracts informed consent, they may be withdrawn based on the investigator's determination.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

• Behavioral Variant Frontotemporal Dementia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketogenic diet	Ketogenic diet

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-08-31
• Completion: 2025-10-31
• First posted: 2025-01-07
• Last updated: 2025-02-10