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 range45 Years – 70 Years
SexALL
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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
✕. 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;
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
✕. 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;
Verbal Fluency Test (VFT)
Timeframe: After 4 weeks and 12 weeks of treatment, changes relative to baseline