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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031729
Receipt No. R000036228
Scientific Title Producing booklet for appropriate application of amyloid PET imaging in people with dementia. (Relationship between clnical symptoms and amyloid PET binding in early dementia subjects.)
Date of disclosure of the study information 2018/03/31
Last modified on 2019/06/25

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Basic information
Public title Producing booklet for appropriate application of amyloid PET imaging in people with dementia. (Relationship between clnical symptoms and amyloid PET binding in early dementia subjects.)
Acronym Producing booklet for amyloid PET imaging
Scientific Title Producing booklet for appropriate application of amyloid PET imaging in people with dementia. (Relationship between clnical symptoms and amyloid PET binding in early dementia subjects.)
Scientific Title:Acronym Producing booklet for amyloid PET imaging
Region
Japan

Condition
Condition Dementia
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To produce a booklet for clinician, regarding indication for amyloid PET, imaging test which determines whether the cause of the dementia is due to Alzheimer's disease or not.
Basic objectives2 Others
Basic objectives -Others (1)Produce referral letter for ordering amyloid PET imaging for local clinician.
(2) Produce result letter to ordering clinician.
(3) Produce a booklet for appropriate indication of amyloid PET imaging in person with dementia.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic change of subject with dementia by result from florbetapir PET imaging.
Key secondary outcomes Adverse effect of florbetapir PET.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Florbetapir PET scanned once.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Atypical clinical symptom or age of onset for dementia.
(2)Mild to moderate cognitive impairment.
Key exclusion criteria (1)Delirium
(2)Depression
(3)Drug induced cognitive decline
(4)Pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shigeki
Middle name
Last name Hirano
Organization Chiba University Hospi9tal, Chiba, Japan
Division name Department of Neurology
Zip code 260-8670
Address 1-8-1Inohana,Chuo-ku,Chiba-shi,Chiba260-8670,Japan
TEL 043-226-2736
Email s_hirano@chiba-u.jp

Public contact
Name of contact person
1st name Shigeki
Middle name
Last name Hirano
Organization Chiba University Hospital
Division name Clinical Trial Department
Zip code 260-8670
Address 1-8-1Inohana,Chuo-ku,Chiba-shi,Chiba260-8670,Japan
TEL 043-226-2736
Homepage URL
Email s_hirano@chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization Eli Lilly Japan Ltd.
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 IRB comittee, Chiba University Hospital, Chiba, Japan
Address 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel 043-226-2616
Email ayamazaki@office.chiba-u.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 千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 03 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 15
Results
Out of 15 subjects who underwent amyloid PET, 2 corticobasal syndrome and 1 non-Alzheimer type senile dementia changed the diagnosis by the PET result.
Results date posted
2019 Year 06 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Six Alzheimer's disease, 5 corticobasal syndrome, 1 dementia with Lewy bodies, 2 non-Alzheimer type senile dementia.
Participant flow
All participants underwent neuropsychological tests and Florbetapir PET.
Adverse events
None
Outcome measures
Florbetapir PET
Plan to share IPD Data are stocked in the data center, Chiba University Hospital.
IPD sharing Plan description Above.

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 31 Day
Date of IRB
2018 Year 03 Month 14 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036228

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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