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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036908
Receipt No. R000042060
Scientific Title A dementia study by 11C-PiB, 18F-FDG PET
Date of disclosure of the study information 2019/05/31
Last modified on 2019/06/04

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Basic information
Public title A dementia study by 11C-PiB, 18F-FDG PET
Acronym A dementia study by 11C-PiB, 18F-FDG PET
Scientific Title A dementia study by 11C-PiB, 18F-FDG PET
Scientific Title:Acronym A dementia study by 11C-PiB, 18F-FDG PET
Region
Japan

Condition
Condition mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.
Classification by specialty
Neurology Geriatrics Psychiatry
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to clarify the condition of dementia by 11C-PiB, 18F-FDG PET evaluating changes in brain lesions over time in dementia and the relationship between brain lesions and cognitive functions.
Basic objectives2 Others
Basic objectives -Others pathophysiology
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Differences in glucose metabolism , degree of accumulation of amyloid, accumulation site of amyloid by disease
Key secondary outcomes Relationship between clinical features and glucose metabolism, degree and site of amyloid accumulation

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 11C-PiB, 18F-FDG PET
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

Not applicable
Gender Male and Female
Key inclusion criteria Persons who were visited to our hospital and diagnosed with dementia or mild cognitive impairment and given an agreement on the PET study
Key exclusion criteria 1. Persons with other serious illnesses or unstable conditions,
2. Persons suffering from deformities / disorders of spine or hip with pain in resting position,
3. Persons judged inappropriate by doctor or the chief researcher
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Toshihisa
Middle name
Last name Tajima
Organization Nagoya City Rehabilitation Agency
Division name Bureau of Planning and Research
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Email ttajimat@gmail.com

Public contact
Name of contact person
1st name Toshihisa
Middle name
Last name Tajima
Organization Nagoya City Rehabilitation Agency
Division name Bureau of Planning and Research
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Homepage URL
Email ttajimat@gmail.com

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya City Rehabilitation Agency
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel 052-835-3811
Email soumubu@nagoya-rehab.or.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 名古屋市総合リハビリテーション事業団(愛知県)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 31 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 05 Month 20 Day
Date of IRB
2019 Year 05 Month 29 Day
Anticipated trial start date
2019 Year 05 Month 31 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 05 Month 31 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042060

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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