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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024491
Receipt No. R000028188
Scientific Title A dementia study by amyloid and tau PET
Date of disclosure of the study information 2016/10/19
Last modified on 2016/10/19

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Basic information
Public title A dementia study by amyloid and tau PET
Acronym ADSAT
Scientific Title A dementia study by amyloid and tau PET
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Kato
Organization National Center for Geriatrics and Gerontology
Division name Department of Radiology
Zip code
Address 7-430 Morioka, Obu, Aichi 474-8522, Japan
TEL 0562-46-2311
Email tkato@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Kato
Organization National Center for Geriatrics and Gerontology
Division name Department of Radiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2016 Year 08 Month 22 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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