The Ketogenic Diet in the Treatment of Behavioral Variant Frontotemporal Dementia

NCT06761729 | Not Yet Recruiting

• 1 other identifier: XWYY-bvFTD-01
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Behavioral Variant Frontotemporal Dementia

Outcome Measures

Primary Outcomes (8)

• Montreal Cognitive Assessment (MoCA)

  After 4 and 12 weeks of treatment, the changes in MoCA scores compared to the baseline MoCA evaluates various cognitive domains including attention, executive functions, memory, language, visuospatial skills, abstraction, calculation, and orientation. It takes about 10 minutes to administer and is scored out of 30 points, with a score of 26 or above considered normal.

  After 4 and 12 weeks of treatment, changes in MoCa scores relative to baseline.

• Mini-Mental State Examination (MMSE)

  After 4 and 12 weeks of treatment, changes in MMSE score compared to the baseline. MMSE tests cognitive function in five areas: orientation, registration, attention and calculation, recall, and language. It consists of 11 questions, with total score ranging from 0-30 points. Lower score indicate greater cognitive impairment.

  After 4 and 12 weeks of treatment, changes in MMSE score relative to baseline.

• Clinical Dementia Rating (CDR) scale

  After 4 and 12 weeks of treatment, changes in CDR score compared to the baseline. CDR assess the progression of dementia, it evaluates six cognitive domains: memory, orientation, judgment/problem solving, community affairs, home and hobbies, and personal care. The CDR provides both a global score and a "Sum of Boxes" score, which ranges from 0 to 18. Higher scores on the CDR indicate more severe dementia.

  After 4 weeks and 12 weeks of treatment, changes relative to baseline

• Frontal Assessment Battery (FAB)

  After 4 and 12 weeks of treatment, changes in FAB score compared to the baseline. FAB assess frontal lobe functions, with tasks evaluating conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control, and environmental autonomy. The total maximum score is 18, with higher scores indicating better performance.

  After 4 weeks and 12 weeks of treatment, changes relative to baseline

• Neuropsychiatric Inventory (NPI)

  After 4 and 12 weeks of treatment, changes in NPI score compared to the baseline It evaluates 12 domains including delusions, hallucinations, and apathy, with severity rated from 1 to 3 and frequency from 1 to 4. Higher scores indicate more severe symptoms.

  After 4 weeks and 12 weeks of treatment, changes relative to baseline

• Frontal Behavioral Inventory (FBI)

  After 4 and 12 weeks of treatment, changes in FBI score compared to the baseline. The FBI is a 24-item caregiver questionnaire that measures behaviors associated with frontal lobe dysfunction, such as apathy and disinhibition. It uses a four-point scale for each item and is scored based on caregiver responses, with higher scores indicating greater impairment.

  After 4 weeks and 12 weeks of treatment, changes relative to baseline

• Boston Naming Test (BNT)

  After 4 and 12 weeks of treatment, changes in BNT score compared to the baseline. BNT score changes from baseline after 4 and 12 weeks of treatment. The BNT is a quantitative measure of confrontation naming ability, consisting of 60 line drawings of objects. It assesses dysnomia and is sensitive in detecting naming difficulties compared to physical object naming.

  After 4 weeks and 12 weeks of treatment, changes relative to baseline

• Verbal Fluency Test (VFT)

  After 4 and 12 weeks of treatment, changes in VFT score compared to the baseline.The VFT involves generating words within a category or starting with a specific letter within a time limit. It measures executive functions and language use, with fewer words indicating potential cognitive deficits.

  After 4 weeks and 12 weeks of treatment, changes relative to baseline

Secondary Outcomes (1)

• Comparison of the variations in blood ketone values relative to baseline during the treatment period

  During the 12-week treatment course

Study Arms (1)

Ketogenic diet

EXPERIMENTAL

The subjects initially enter the screening phase (≤ 2 weeks); they undergo the titration period (1 week), gradually titrating to the maximum dose stipulated in the protocol or the maximum tolerable dose for the subject; during the treatment period (12 weeks), but if intolerance emerges during the treatment, the subject can revert to the previous tolerated dose for continued treatment. The dosage was titrated incrementally until reaching the maximum daily dose of 30g \* 3 meals a day as stipulated in the protocol or the maximum tolerable daily dose for the subject. After entering the treatment period (from week 2 to week 13), this dose was maintained for 12 weeks.

Dietary Supplement: Ketogenic diet

Interventions

Ketogenic diet DIETARY_SUPPLEMENT

Ketogenic diet

Ketogenic diet

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between the ages of 45 - 70;
• Meetting the diagnostic criteria for "probable bvFTD published by the International bvFTD Standards Consortium in 2011;
• Subjects must not undergo any drug adjustment treatment for 2 months prior to the enrollment and during the enrollment period ;
• Subjects must sign a written informed consent form prior to the screening visit examination. If the subject cannot sign due to limited cognitive ability or other reasons, the signature may be left blank, and the rationale must be stated. The legal guardian should provide the reason, sign the name, date, and time in the reason description area, and also sign the name, date, and time in the legal guardian column.

You may not qualify if:

• Subject is between the ages of 45 - 70;
• Meetting the diagnostic criteria for "probable bvFTD published by the International bvFTD Standards Consortium in 2011;
• Subjects must not undergo any drug adjustment treatment for 2 months prior to the enrollment and during the enrollment period ;
• Subjects must sign a written informed consent form prior to the screening visit examination. If the subject cannot sign due to limited cognitive ability or other reasons, the signature may be left blank, and the rationale must be stated. The legal guardian should provide the reason, sign the name, date, and time in the reason description area, and also sign the name, date, and time in the legal guardian column.
• Dementia caused by other factors: Alzheimer's Disease，vascular dementia, central nervous system infections (such as AIDS, syphilis, etc.), Huntington's disease and Parkinson's disease, Lewy body dementia, traumatic brain injury dementia, other physical and chemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), significant somatic diseases (such as hepatic encephalopathy, pulmonary etc.), intracranial space-occupying lesions (such as subdural hematoma, brain tumors), endocrine system disorders (such as thyroid diseases, parathyroid diseases) and dementia caused by vitamin deficiency or any other known causes;
• Having a low-carb diet , ketogenic diet, or vegan diet within 3 months before the screening visit or being currently doing.
• Patients diagnosed with schizophrenia spectrum disorder ,bipolar disorder, moderate to severe depression or delirium according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• Abnormal laboratory tests at screening visit and baseline: including liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]) exceeding twice the upper limit of normal; and renal function (creatinine \[Cr\]) exceeding 1.5 times the upper limit of normal. Slight exceedances that are not clinically significance, as judged by the investigator, may not be excluded;
• Fasting triglycerides ≥ 5.7 mmol/L or total cholesterol ≥ 10.34 mmol/L at the screening visit and baseline;
• Presence any of the following infections at the screening visit:
• Positive human immunodeficiency virus antibody (HIV Ab); Positive Treponema pallidum antibody (TP Ab);
• Gastrointestinal diseases that could affect the absorption or metabolism of the investigational product as judged by the investigator, within 2 months before the screening visit;
• Having undergone major surgeries deemed unsuitable for enrollment by the investigator within 6 months before the screening visit or those planning to undergo major surgeries during the study period (The definition of major surgeries refers to Grade 3 and Grade 4 surgeries as outlined in the "Administrative Measures for Grading of Surgeries in Medical Institutions (Trial)" implemented on December 6, 2022);
• Patients who have suffered from malignant tumors within 3 years prior to the screening visit (excluding basal cell carcinoma of the skin that has been radically cured, squamous cell carcinoma of the skin and/or carcinoma in situ that has been radically resected);
• Having a history of alcohol or drug abuse within 1 year prior to the screening visit;

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Longfei Jia, Dr.

CONTACT

0086-10 - 83199449; jialongfei@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment,

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 7, 2025
• Study Start: February 10, 2025
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share