The Ketogenic Diet in the Treatment of Behavioral Variant Frontotemporal Dementia (NCT06761729) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Ketogenic Diet in the Treatment of Behavioral Variant Frontotemporal Dementia
3 participantsStarted 2025-02-10
Plain-language 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.
Who can participate
Age range
45 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Montreal Cognitive Assessment (MoCA)
Timeframe: After 4 and 12 weeks of treatment, changes in MoCa scores relative to baseline.
2
Mini-Mental State Examination (MMSE)
Timeframe: After 4 and 12 weeks of treatment, changes in MMSE score relative to baseline.
3
Clinical Dementia Rating (CDR) scale
Timeframe: After 4 weeks and 12 weeks of treatment, changes relative to baseline
4
Frontal Assessment Battery (FAB)
Timeframe: After 4 weeks and 12 weeks of treatment, changes relative to baseline
5
Neuropsychiatric Inventory (NPI)
Timeframe: After 4 weeks and 12 weeks of treatment, changes relative to baseline
6
Frontal Behavioral Inventory (FBI)
Timeframe: After 4 weeks and 12 weeks of treatment, changes relative to baseline
7
Boston Naming Test (BNT)
Timeframe: After 4 weeks and 12 weeks of treatment, changes relative to baseline
. 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;
8
Verbal Fluency Test (VFT)
Timeframe: After 4 weeks and 12 weeks of treatment, changes relative to baseline