The Ketogenic Diet in the Treatment of Behavioral Variant Frontotemporal Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Ketogenic diet
Dietary supplementKetogenic diet
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Ketogenic dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
After 4 and 12 weeks of treatment, changes in MoCa scores relative to baseline.2
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.
Time frame
After 4 and 12 weeks of treatment, changes in MMSE score relative to baseline.3
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.
Time frame
After 4 weeks and 12 weeks of treatment, changes relative to baseline4
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.
Time frame
After 4 weeks and 12 weeks of treatment, changes relative to baselineSecondary outcomes
1
Comparison of the variations in blood ketone values relative to baseline during the treatment period
This measure compares the variations in blood ketone levels relative to the baseline during the treatment period. It also examines the influence of blood ketone levels on cognitive function; higher blood ketone levels are associated with improved cognitive function and therapeutic efficacy.
Time frame
During the 12-week treatment courseLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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