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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031753
Receipt No. R000035992
Scientific Title Research for the making of materials for proper usage of amyloid PET
Date of disclosure of the study information 2018/05/01
Last modified on 2019/06/12

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Basic information
Public title Research for the making of materials for proper usage of amyloid PET
Acronym Making of educational materials for proper usage of amyloid PET
Scientific Title Research for the making of materials for proper usage of amyloid PET
Scientific Title:Acronym Making of educational materials for proper usage of amyloid PET
Region
Japan

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

Objectives
Narrative objectives1 The establishment of educational materials for proper usage of amyloid PET by an Alzheimer's disease specialist, based on the knowledge obtained through clinical experience of amyloid PET scan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Evaluation of difference in diagnosis considered from MRI and SPECT and from additional amyloid PET
2. Evaluation on understanding and consent of diagnosis by adding information necessary for explaining the diagnosis to patients
Key secondary outcomes 1. Validation of the NIA-AA clinical diagnostic criteria.
2. Validation of the clinical symptoms, psychological tests and imaging findings in the patients with negative amyloid PET
3. Physiological test

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
Medicine
Interventions/Control_1 Inquiry, physical examination, psychological tests, clinical examination, brain MRI and amyloid PET are performed.
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 1) The age of the time of the informed consent is more than 20 years old.
2) Atypical dementia fulfilling the diagnostic criteria of NIA-AA.
Key exclusion criteria 1) Screening MRI shows infection, cerebral infarction and brain tumor affecting the cognition function.
2) Unsuitable patients for MRI because of a pacemaker, an aneurysm clip, an artificial valve, an artificial labyrinth and metal of electrical conduction property and magnetized body or claustrophobia.
3) Previous history of major depression or bipolar disorder as defined in DSM-IV within 1 year, or history of schizophrenia as defined in DSM-IV.
4) Previous history of alcohol or drug addiction as defined in DSM-IV within the past 2 years.
5) Patients with psychiatric symptoms, excitability, or behavior abnormalities that make it difficult to follow the protocol within the past 3 months.
6) Severe systemic illness such as uncontrollable hypertension, diabetes, cardiac disorder etc, and diseases that are unstable in conditions that affect clinical evaluation.
7) Patients with severe drug allergy or alcohol hypersensitivity.
8) Patients who cannot keep at rest in the examination
9) The patients with Vitamin B 12 deficiency, syphilis, abnormal thyroid function.
10) The patients in other clinical trial.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mana
Middle name
Last name Ishibashi
Organization Faculty of Medicine, Tottori University
Division name Division of Radiology
Zip code 683-8504
Address 36-1 Nishicho, Yonago city, Tottori
TEL 0859-38-6637
Email manai@tottori-u.ac.jp

Public contact
Name of contact person
1st name Mana
Middle name
Last name Ishibashi
Organization Faculty of Medicine, Tottori University
Division name Division of Radiology
Zip code 683-8504
Address 36-1 Nishicho, Yonago city, Tottori
TEL 0859-38-6637
Homepage URL
Email manai@tottori-u.ac.jp

Sponsor
Institute Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Faculty of Medicine, Tottori University
Address 36-1 Nishicho, Yonago city, Tottori
Tel 0859-38-1111
Email me-rinshoukenkyu@ml.adm.tottori-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 鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 01 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 20
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
2018 Year 03 Month 01 Day
Date of IRB
2018 Year 01 Month 22 Day
Anticipated trial start date
2018 Year 05 Month 01 Day
Last follow-up date
2018 Year 12 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
2018 Year 03 Month 15 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035992

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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