UMIN-CTR Clinical Trial

Public title

Comprehensive and longitudinal study for neurodegenerative dementia using [11C]PBB3 positron emission tomography

Acronym

Comprehensive and longitudinal study for dementia using [11C]PBB3 positron emission tomography

Scientific Title

Comprehensive and longitudinal study for neurodegenerative dementia using [11C]PBB3 positron emission tomography

Scientific Title:Acronym

Comprehensive and longitudinal study for dementia using [11C]PBB3 positron emission tomography

Region

Japan

Condition

The dementia includes mild cognitive impairment, Alzheimer's disease, frontemporal degeneration, Lewy body disease, Parkinson's disease with dementia, corticobasal degeneration, progressive supranuclear palsy. Morever, subjects with hypertension, hyperglycemia (diabetes), and hyperlipidemia, which associate with dementia, are also included.

Classification by specialty

Neurology	Geriatrics	Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to make the tau imaging study developed in our institute using positron emission tomography in neurodegenerative dementia precisely by longitudinal and comprehensive assessment.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The association of the changes observed in amyloid imaging ([11C]PIB-PET) and tau imaging ([11C]PBB3-PET) with their clinical progression of the disease such as their cognitive decline.

Key secondary outcomes

The contribution of risk factor such as hypertension, hyperglycemia (diabetes), and hyperlipidemia to the cerebral amyloid/tau load or the pathophysiology of the dementia.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Both the disease severity and treatment is not considered for the criteria. With respect to subjects with hypertension, hyperglycemia, and hyperlipidemia, overlapping disease is approved.

Key exclusion criteria

The subject who have already took part in the previous examination in the study of dementia using [11C]PBB3 PET imaging in a year is excluded.

Target sample size

180

Name of lead principal investigator

1st name
Middle name
Last name	Hitoshi Shimada

Organization

National Institute of Radiological Sciences, Molecular Imaging Center

Division name

Molecular Neuroimaging Program

Zip code

Address

4-9-1, Anagawa, Inage-ku, Chiba, Japan

TEL

043-206-3251

Email

shimada@nirs.go.jp

Name of contact person

1st name
Middle name
Last name	Hitoshi Shimada

Organization

National Institute of Radiological Sciences, Molecular Neuroimaging Center

Division name

Molecular Neuroimaging Program

Zip code

Address

4-9-1, Anagawa, Inage-ku, Chiba, Japan

TEL

043-206-3251

Homepage URL

Email

shimada@nirs.go.jp

Institute

National Institute of Radiological Sciences

Institute

Department

Personal name

Organization

National Institute of Radiological Sciences

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

06

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2015

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2015

Year

06

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

During the visit for the examinations including PET scans, clinical interview, physical examination with measurement of blood pressure and body mass index, and several psychometric tests are performed. Moreover, blood sampling for the assessment of metabolic syndrome associated with diabetes and hyperlipidemia is also performed (if not yet done) when intravenous injection on PET scans is carried out.
Neuroimage processing in MRI, [11C]PIB-PET, [11C]PBB3-PET, and [18F]FDG-PET is conducted in Molecular Imaging Center, National Institute of Radiological Sciences. In the future, statistical comparisons between disease and control groups and discussions with clinical information including metabolic syndrome are going to be held.

Registered date

2015

Year

06

Month

19

Day

Last modified on

2015

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020826