UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036908
Receipt number 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 11:15:27

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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 or person

Institute

Nagoya City Rehabilitation Agency

Institute

Department

Personal name



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

Value
https://center6.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