UMIN-CTR Clinical Trial

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