UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Alzheimer disease patients and healthy controls in easy Z-score imaging system with differential image reconstruction methods using SPECT/CT: Verification using normal database of our institution
Acronym	Comparison of AD and Healthy in eZIS with differential image reconstruction methods using SPECT/CT: Verification using NDB of our institution
Scientific Title	Comparison of Alzheimer disease patients and healthy controls in easy Z-score imaging system with differential image reconstruction methods using SPECT/CT: Verification using normal database of our institution
Scientific Title:Acronym	Comparison of AD and Healthy in eZIS with differential image reconstruction methods using SPECT/CT: Verification using NDB of our institution
Region	Japan

Condition
Condition	Alzheimer disease
Classification by specialty	Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The present study aimed to construct an AD-specific VOI using e-ZIS-assisted 99mTc-ethyl cysteinate dimer (ECD) SPECT/CT images. In addition, we compared the differential diagnostic ability between HC and patients with AD using the FBP and OSEM image reconstruction methods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In order to verify the difference between the two types of image reconstruction, we will create a VOI for eZIS analysis from the data of AD patients and healthy controlts acquired at our institution. eZIS analysis is performed on the analysis data, and ROC analysis is used to evaluate which of the image reconstruction FBP and OSEM methods has the higher differential diagnosis ability.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	50 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	AD patients: Detailed interview with a psychiatrist and patients positive for 11C-PiBPET Healthy controls: Those who do not have organic diseases by MRI etc.
Key exclusion criteria	Patients who are unsuitable for physical activity or test data during the test
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Ohba
Organization	Yamagata University Hospital
Division name	Department of Radiology
Zip code	990-9585
Address	2-2-2 Iida-Nishi, Yamagata, 990-9585 Japan
TEL	0236331122
Email	m-ohba@med.id.yamagata-u.ac.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Ohba
Organization	Yamagata University Hospital
Division name	Department of Radiology
Zip code	990-9585
Address	2-2-2 Iida-Nishi, Yamagata, 990-9585 Japan
TEL	0236331122
Homepage URL
Email	m-ohba@med.id.yamagata-u.ac.jp

Sponsor
Institute	Yamagata University Hospital
Institute
Department

Funding Source
Organization	Yamagata University Hospital
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	the Ethical Review Committee of Yamagata University Faculty of Medicine
Address	2-2-2 Iida-Nishi, Yamagata, 990-9585 Japan
Tel	023-635-5047
Email	ikekenkyu@jm.kj.yamagata-u.ac.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

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 10 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	102
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	Completed
Date of protocol fixation	2020 Year 03 Month 30 Day
Date of IRB	2017 Year 06 Month 30 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2020 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Paper submission schedule

Management information
Registered date	2020 Year 11 Month 05 Day
Last modified on	2020 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048359