UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012299
Receipt No. R000014383
Scientific Title Development of systematic diagnosis of Alzheimer disease and its related diseases using gene analysis, amloid imaging and spinal fluid analysis.
Date of disclosure of the study information 2013/11/14
Last modified on 2019/05/20 (Ver. 13)

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Basic information
Public title Development of systematic diagnosis of Alzheimer disease and its related diseases using gene analysis, amloid imaging and spinal fluid analysis.
Acronym Systematic diagnosis of Alzheimer disease with gene analysis, amloid imaging and spinal fluid analysis.
Scientific Title Development of systematic diagnosis of Alzheimer disease and its related diseases using gene analysis, amloid imaging and spinal fluid analysis.
Scientific Title:Acronym Systematic diagnosis of Alzheimer disease with gene analysis, amloid imaging and spinal fluid analysis.
Region
Japan

Condition
Condition patients with dementia and its related diseases
Classification by specialty
Geriatrics Radiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Development of systematic diagnosis of dementia and its related diseases using gene analysis, amyloid imaging, and spinal fluid analysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Development of systematic diagnostic decision tree in patients with dementia and its related diseases, including gene analysis, amyloid imaging, and spinal fluid analysis.
Key secondary outcomes Evaluation of prognostic usefulness of systematic diagnostic decision tree in patients with mild cognitive imapairment who developed dementia later.

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 injection of radioisotope
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 patients with dementia and its related diseases
Key exclusion criteria none
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name Chio
Middle name
Last name Okuyama
Organization Shiga Medical Center Research Institute
Division name Division of PET Imaging
Zip code 524-8524
Address Moriyama
TEL 077-582-6034
Email okuyama@res.med.shiga-pref.jp

Public contact
1st name of contact person
1st name Shigenori
Middle name
Last name Shimomura
Organization Shiga Medical Center, Research Institute
Division name head office
Zip code 524-8524
Address Moriyama
TEL 0775-82-6034
Homepage URL http://www.shigamed.jp/
Email kenkyu@res.med.shiga-pref.jp

Sponsor
Institute Shiga Medical Center
Institute
Department

Funding Source
Organization Shiga Medical Center Research Institute
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Patho-Functional Bioanalysis
Graduate School of Pharmaceutical Sciences, KYOTO UNIVERSITY
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB at Shiga General Hospital
Address 5-4-30, Moriyama,
Tel 077-582-6034
Email kenkyu@res.med.shiga-pref.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 滋賀県立総合病院研究所

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 14 Day

Related information
URL releasing protocol http://www.shigamed.jp/
Publication of results Partially published

Result
URL related to results and publications http://www.shigamed.jp/
Number of participants that the trial has enrolled 55
Results 
Part of the results has been published in Annals of Nuclear Medicine (2018) 32: 2016-216.

It was confirmed that this new tracer has the equivalent prognostic value in the evaluation of the amyloid deposition.

However, we could not easily obtain the consent to get the gene to evaluate apoE e4 gene, so that we have decided to stop this study.
Results date posted
2019 Year 05 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 01 Month 31 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2013 Year 09 Month 25 Day
Date of IRB
2013 Year 09 Month 25 Day
Anticipated trial start date
2013 Year 10 Month 04 Day
Last follow-up date
2023 Year 10 Month 01 Day
Date of closure to data entry
2023 Year 10 Month 01 Day
Date trial data considered complete
2024 Year 04 Month 01 Day
Date analysis concluded
2024 Year 04 Month 01 Day

Other
Other related information A part of data was published at 54th Annual Meeting of Japanese Society of Nuclear Medicine.

Management information
Registered date
2013 Year 11 Month 14 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014383