UMIN-CTR Clinical Trial

Basic information
Public title	Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Acronym	Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Scientific Title	Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Scientific Title:Acronym	Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology Psychiatry Radiology Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim is to evaluate preclinical AD and MCI due to AD using PET amyloid imaging as a beta amyloid biomarker,and to clarify the progression of pre-symptomatic stage to AD dementia.
Basic objectives2	Others
Basic objectives -Others	Understanding of the pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)To investigate the deposits of beta-amyloid in brain cortex. 2)Degree of impairment of cognitive function correlate with beta-amyloid.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Three-dimensional Dynamic PET images of the brain will be acquired for 60min after intravenous administration of [11C-PIB](about 550 mBq ).
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	40 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Written informed consent was obtained from patient or his/her family.
Key exclusion criteria	The past or present history of psychiatric, disorders, cerebrovascular disease, degenerative disease of the brain and head injury.
Target sample size	160

Research contact person
Last name of lead principal investigator	1st name Shizuo Middle name Last name Hatashita
Organization	Shonan Atsugi Hospital
Division name	Neurosurgery
Zip code	243-8551
Address	Nukumizu118-1 Atsugi-City, Kanagawa, Japan
TEL	046-223-3636
Email	tiken2@shonan-atsugi.jp

Public contact
1st name of contact person	1st name Shizuo Middle name Last name Hatashita
Organization	Shonan Atsugi Hospital
Division name	Neurosurgery
Zip code	243-8551
Address	Nukumizu118-1 Atsugi-City, Kanagawa, Japan
TEL	046-223-3636
Homepage URL
Email	tiken2@shonan-atsugi.jp

Sponsor
Institute	Shonan Atsugi Hospital
Institute
Department

Funding Source
Organization	None
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	Tokushukai Group Ethical Comittee
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo
Tel	03-3263-4801
Email	mirai-ec1@mirai-iryo.com

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 04 Month 18 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	Open public recruiting
Date of protocol fixation	2019 Year 03 Month 14 Day
Date of IRB	2019 Year 04 Month 15 Day
Anticipated trial start date	2019 Year 04 Month 18 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 15 Day
Last modified on	2019 Year 04 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041240