HED-TRC

JRCT ID: jRCT1031230633

Registered date:14/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hereditary Dementia
• Date of first enrollment: 14/02/2024
• Target sample size: 55
• Study type: Observational

Outcome(s)

• Primary Outcome: MMSE, Cognitive function score by CDR-SB
• Secondary Outcome: Plasma biomarkers

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Provide written informed consent of their own free will from the patient or a representative.
2. 12 years or older at the time of informed consent.
3. Have a study partner that is willing to participate as a source of information and has approximately weekly contact with the participant (contact can be in-person, via telephone or electronic communication).
4. Approximately healthy without severe current or past medical history which hinder research participation.
5. Have sufficient eyesight and hearing to undergo neuropsychological examinations.
6. Have sufficient Japanese ability.

Exclude criteria

1. History within 3 months of psychosis, agitation, or behavior problem which interfere study protocol.
2. Have a history of alcohol or substance use disorder defined by DSM-V within 2 years.
3. In the unstable medical condition judged by the investigator that pose risks or that interfere research result or subject's performance. It includes uncontrolled hypertension, uncontrolled diabetes, clinically serious heart, lung, kidney, liver, endocrine, or systemic disease.
4. History of primary or recurrent malignant cancer within the past 3 years, except for non-melanoma skin cancer, removed squamous cell carcinoma, basal cell carcinoma, cervical intraepithelial neoplasia, or non-invasive prostate cancer with normal PSA after treatment.
5. With an ineligibility judged by the principal investigator.

Related Information

• Primary Sponsor: Yoshiki Sekijima
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development
• Secondary ID(s): N/A