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
Qualifiers
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
Treatments tested in this trial
- Ketogenic diet
Treatment groups
3 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov