臨床研究等提出・公開システム

Date of registration	Feb. 14, 2024
Last modified on	April. 03, 2026
Trial ID	jRCT1031230633

Scientific Title	Hereditary Dementia Trial Ready Cohort in Japan (HED-TRC)
Public Title	HED-TRC (HED-TRC)

Contact for Scientific Queries	Name	Yoshiki Sekijima
	Affiliation	Shinshu University
	Address	3-1-1, Asahi, Matsumoto City
	Telephone	+81-263-37-2671
	E-mail	sekijima@shinshu-u.ac.jp
Contact for Public Queries	Name	Yoshiki Sekijima
	Affiliation	Shinshu University
	Address	3-1-1, Asahi, Matsumoto City
	Telephone	+81-263-37-2671
	E-mail	sekijima@shinshu-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Feb. 14, 2024
Target sample size		100
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion 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.
	Exclusion 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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Hereditary Dementia
Health Condition(s) Keyword		Hereditary Dementia (Alzheimer's disease, Frontotemporal dementia, Lewy body dementia, Vascular dementia, Cerebral white matter dementia, etc.)
Health Condition(s) Code		D003704
Primary Outcome(s)		MMSE, Cognitive function score by CDR-SB
Secondary Outcome(s)		Plasma biomarkers

Primary Sponsor	Nihon Medi-Physics Co., Ltd.

Primary Sponsor	PDRadiopharma Inc.

Secondary Sponsor

Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Shinshu University Certified Review Board of Clinical Research
Address	3-1-1, Asahi, Matsumoto City, Nagano
Telephone	+81-263-37-2572
E-Mail	md_rinri@shinshu-u.ac.jp
Approval Status	Approval
Date of approval	Jan. 18, 2024

Plan to share IPD	No

Secondary ID(s)	N/A
Issuing Authority	N/A

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	April. 03, 2026	(this page)	Changes
3	Feb. 20, 2026	Detail	Changes
2	June. 07, 2024	Detail	Changes
1	Feb. 14, 2024	Detail

List of change history