UMIN-CTR Clinical Trial

Basic information
Public title	Observational study on patients with mild cognitive impairment by using amyloid PET
Acronym	Observational study on patients with mild cognitive impairment by using amyloid PET
Scientific Title	Observational study on patients with mild cognitive impairment by using amyloid PET
Scientific Title:Acronym	Observational study on patients with mild cognitive impairment by using amyloid PET
Region	Japan

Condition
Condition	mild cognitive impairment
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between amyloid PET-positive findings and the onset of Alzheimer-type dementia by conducting amyloid PET tests in patients with mild cognitive impairment and observing the subsequent course.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection rate of early dementia based on amyloid PET test
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Age at the time of obtaining consent is 20 years old or older, regardless of gender. 2. After verbal and written explanation, consent from the subject has been obtained in writing about participation. 3. Patients with mild cognitive impairment and clinically suspected Alzheimer type dementia as background pathology
Key exclusion criteria	1) Persons who are judged to be inappropriate by the person in charge or in charge of participation in this clinical study 2) Those who have an implantable device such as a pacemaker
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Ikeda
Organization	Osaka University Graduate School
Division name	Department of Medicine, Department of Psychiatry
Zip code	565-0871
Address	2-2 D3, Yamadaoka, Suita City, Osaka Prefecture
TEL	0668793051
Email	mikeda@psy.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Hata
Organization	Osaka University Graduate School
Division name	Department of Medicine, Department of Psychiatry
Zip code	565-0871
Address	2-2 D3, Yamadaoka, Suita City, Osaka Prefecture
TEL	0668793051
Homepage URL
Email	mhata@psy.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita City, Osaka Prefecture
Tel	06-6210-8289
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	2019 Year 11 Month 12 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	Enrolling by invitation
Date of protocol fixation	2019 Year 10 Month 25 Day
Date of IRB	2019 Year 10 Month 25 Day
Anticipated trial start date	2019 Year 11 Month 12 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2019 Year 11 Month 11 Day
Last modified on	2021 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043926