Behavioral variant frontotemporal dementia
Conditions
Interventions
Experimental group:JT821 intervention
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Age 45-70 years old, gender is not limited; (2) meet the diagnostic criteria for "probable bvFTD" published by the International bvFTD Standards Consortium in 2011; (3) No medication adjustments 2 months prior to enrollment and during enrollment; (4) Subjects must sign a written informed consent form prior to the screening visit examination. If the subject cannot sign due to cognitive limitations or other reasons, the subject's signature is allowed to be left blank and the reason is stated, and the legal guardian is required to sign the reason statement, and the legal guardian is required to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Other causes of dementia: Alzheimer's disease, vascular dementia, central nervous system infections (such as AIDS, syphilis, etc.), Huntington's disease and Parkinson's disease, dementia with Lewy bodies, Traumatic brain dementia, other physical and chemical factors (such as drug intoxication, alcohol intoxication, carbon monoxide poisoning, etc.), important medical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial mass venereal disease changes (e.g., subdural hematoma, brain tumors), endocrine system pathologies (e.g., thyroid disease, parathyroid disease), and vitamin deficiencies or any other known cause of dementia; (2) Within 3 months prior to the screening visit or currently receiving dietary therapies such as a low-carb diet, ketogenic diet, or vegan diet; (3) Prior or current diagnosis of schizophrenia spectrum disorder, bipolar disorder, moderate to severe depression, or delirium according to DSM-5; (4) Abnormal laboratory examination at screening: liver function (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) exceeding the upper limit of normal range by 2 times; Renal function (creatinine [Cr]) greater than 1.5 times the upper limit of the normal range; Those judged by the investigator to be mildly beyond this range but not clinically significant may not be excluded; (5) Fasting triglycerides >=5.7mmol/L or total cholesterol >=10.34mmol/L at screening; (6) Presence of any of the following infected persons at the time of screening: positive for human immunodeficiency virus antibody (HIV Ab); Treponema pallidum antibody (TP Ab) positive; (7) Presence of gastrointestinal disease within 2 months prior to screening, as judged by the investigator, to affect the absorption or metabolism of the investigational product; (8) Those who have undergone major surgery within 6 months prior to screening and are judged by the investigator to be unsuitable for enrollment or who plan to undergo major surgery during the study period (the definition of major surgery refers to the level 3 and 4 surgeries specified in the Measures for the Management of Surgical Classification in Medical Institutions (Trial) implemented on December 6, 2022); (9) Malignancy within 3 years prior to the screening visit (excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has undergone radical resection); (10) Alcohol abuse or drug abuse within 1 year prior to the screening visit; (11) Those who are known to be allergic to the ingredients of the product used in this study; (12) Presence of uncorrectable audio-visual impairment or other conditions that affect the scale evaluation; (13) Presence of JT821 dietary contraindications: Absolute contraindications: 1) Type 1 diabetes 2) Primary carnitine deficiency 3) Carnitine palmitoyltransferase (CPT) I and II deficiency 4) Carnitine translocation enzyme deficiency 5) ß-oxidative disorders 6) Medium-chain acyl dehydrogenase deficiency (MCAD) 7) Very long-chain acyl dehydrogenase deficiency (VLCAD) 8) Long-chain acyl dehydrogenase deficiency (LCAD) 9) Short-chain acyl dehydrogenase deficiency (SCAD) 10) Long-chain 3-hydroxyacyl-CoA deficiency 11) Medium-chain 3-hydroxyacyl-CoA deficiency 12) Pyruvate carboxylase deficiency 13) Porphyria 14) Acute pancreatitis 15) Liver failure 16) Pregnancy Relative contraindications: Failure to maintain adequate nutrition (fasting blood glucose < 2.8 mmol/L o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function and psychobehavioral symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood ketone;Safety evaluation; | — |
Countries
China
Contacts
Public ContactLongfei Jia
Capital Medical University Xuanwu Hospital
Outcome results
None listed