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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014346
Receipt No. R000016700
Scientific Title Longitudinal study across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Date of disclosure of the study information 2014/06/24
Last modified on 2018/11/29

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Basic information
Public title Longitudinal study across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Acronym Longitudinal study across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Scientific Title Longitudinal study across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Scientific Title:Acronym Longitudinal study 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 NO

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 Efficacy
Basic objectives -Others
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
55 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1)The patients had underwent 11C-PIB PET in the past.
2)55years old-90years old,male and female.
3)Written informed consent was obtained from patient or his/her family.
Key exclusion criteria 1)The past and present history of alcoholism and epilepsy
2)The past and present history of psychiatric, disorders, cerebrovascular disease, degenerative disease of the brain and head injury.
3)Severe complication including malignancy, heart failure, hepatic dysfunction, renal dysfunction, endocrine disorders, etc
4)Patients treated with antidepressants, antipsychotics,and long-term sedative-hypnotics
5)The patients that investigators need to exclude.
Target sample size 160

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

Public contact
Name of contact person
1st name
Middle name
Last name Shizuo Hatashita
Organization Shonan-Atsugi hospital
Division name Department of neurosurgery
Zip code
Address Nukumizu118-1 Atsugi-City, Kanagawa, Japan
TEL 046-297-7576
Homepage URL
Email tiken2@shonan-atsugi.jp

Sponsor
Institute Shonan-Atsugi hospital
Institute
Department

Funding Source
Organization Department of neurosurgery
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
2014 Year 06 Month 24 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 Completed
Date of protocol fixation
2014 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 23 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016700

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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