Behavioral Variant Frontotemporal Dementia
Conditions
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.
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or if the subject or their legal guardian actively requests to withdraw or retracts informed consent, they may be withdrawn based on the investigator's determination.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.
Interventions
DIETARY_SUPPLEMENTKetogenic diet
Ketogenic diet
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment,
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is between the ages of 45 - 70; 2. Meetting the diagnostic criteria for probable bvFTD published by the International bvFTD Standards Consortium in 2011; 3. Subjects must not undergo any drug adjustment treatment for 2 months prior to the enrollment and during the enrollment period ; 4. 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
Inclusion Criteria: 1. Subject is between the ages of 45 - 70; 2. Meetting the diagnostic criteria for probable bvFTD published by the International bvFTD Standards Consortium in 2011; 3. Subjects must not undergo any drug adjustment treatment for 2 months prior to the enrollment and during the enrollment period ; 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Fluency Test (VFT) | After 4 weeks and 12 weeks of treatment, changes relative to baseline | 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. |
| Montreal Cognitive Assessment (MoCA) | After 4 and 12 weeks of treatment, changes in MoCa scores relative to baseline. | 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. |
| Mini-Mental State Examination (MMSE) | After 4 and 12 weeks of treatment, changes in MMSE score relative to baseline. | 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. |
| Clinical Dementia Rating (CDR) scale | After 4 weeks and 12 weeks of treatment, changes relative to baseline | 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. |
| Frontal Assessment Battery (FAB) | After 4 weeks and 12 weeks of treatment, changes relative to baseline | 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. |
| Neuropsychiatric Inventory (NPI) | After 4 weeks and 12 weeks of treatment, changes relative to baseline | 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. |
| Frontal Behavioral Inventory (FBI) | After 4 weeks and 12 weeks of treatment, changes relative to baseline | 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. |
| Boston Naming Test (BNT) | After 4 weeks and 12 weeks of treatment, changes relative to baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the variations in blood ketone values relative to baseline during the treatment period | During the 12-week treatment course | 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. |
Contacts
Primary ContactLongfei Jia, Dr.
Outcome results
None listed