UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A dementia study by amyloid and tau PET
Title of the study (Brief title)	ADSAT
Region	Japan

Condition
Condition	dementia
Classification by specialty	Neurology Radiology Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Differential diagnosis and pathophysiological investigation of neurodegenerative dementia using amyloid and tau PET
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distribution of amyloid and tau in neurogenerative dementias
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Healthy young volunteer 2) Cognitively Normal elderly (CN) 3) Intermediate between CN and MCI 4) Mild cognitive impairment (MCI) 5) Alzheimer dementia(AD) 6) Non-Alzheimer demantia (nonAD)
Key exclusion criteria	Any significant neurological or psychiatric disease other than dementia Any significant disease such as cancer and heart disease Psychiatric symptoms
Target sample size	200

Research contact person
Name of lead principal investigator	Takashi Kato
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Radiology
Address	7-430 Morioka, Obu, Aichi 474-8522, Japan
TEL	0562-46-2311
Email	tkato@ncgg.go.jp

Public contact
Name of contact person	Takashi Kato
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Radiology
Address	7-430 Morioka, Obu, Aichi 474-8522, Japan
TEL	0562-46-2311
Homepage URL
Email	tkato@ncgg.go.jp

Sponsor
Institute	National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 19 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 08 Month 22 Day
Anticipated trial start date	2016 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a single-site study in Japan. The study design is mainly prospective, but it also analyze available retrospective data sets. Data can be shared with other studies.

Management information
Registered date	2016 Year 10 Month 19 Day
Last modified on	2016 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028188