UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research to evaluate beta-amyloid deposition in the brain of patients with Parkinson's disease with dementia (PDD) and dementia with Lewy bodies (DLB)
Acronym	Amyloid PET studies in PDD and DLB
Scientific Title	Clinical research to evaluate beta-amyloid deposition in the brain of patients with Parkinson's disease with dementia (PDD) and dementia with Lewy bodies (DLB)
Scientific Title:Acronym	Amyloid PET studies in PDD and DLB
Region	Japan

Condition
Condition	Parkinson's disease with dementia (PDD) Dementia with Lewy bodies (DLB)
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate beta-amyloid deposition in the brain of patients with Parkinson's disease with dementia (PDD) and dementia with Lewy bodies (DLB)
Basic objectives2	Others
Basic objectives -Others	To determine whether information and samples obtained from routine clinical practice are predictive of amyloid deposition
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	beta-amyloid deposition in the brain
Key secondary outcomes

Base
Study type	Observational

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
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with PDD or DLB who are attending or being admitted to the Department of Neurology, Juntendo University Hospital, Juntendo University School of Medicine, will be included in the study. PDD is diagnosed as Clinically Established PD or Clinically Probable PD by MDS Clinical Diagnostic Criteria for Parkinson's Disease, and PDD is defined as the onset of Dementia 2 years later. DLB is defined as patients diagnosed with Probable DLB (almost certain) by the Clinical Diagnostic Criteria for Dementia with Lewy Bodies (2017) Amyloid PET and neuropsychological testing can be performed For whom 123I-Ioflupane SPECT testing has been performed IMP-SPECT test performed has been performed
Key exclusion criteria	Age less than 40 years and greater than 81 years at the time consent was obtained Patients with more than moderate multiple cerebral infarctions Those with a history of epileptic seizures within 2 years Other subjects deemed inappropriate as research subjects by the principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Noriko Middle name Last name Nishikawa
Organization	Juntendo University School of Medicine
Division name	Department of Neurology
Zip code	113-8421
Address	2-1-1 Hongo Bunkyo Tokyo
TEL	03-3813-3111
Email	n.nishikawa.ts@juntendo.ac.jp

Public contact
Name of contact person	1st name Noriko Middle name Last name Nishikawa
Organization	Juntendo University School of Medicine
Division name	Department of Neurology
Zip code	113-8421
Address	2-1-1 Hongo Bunkyo Tokyo
TEL	03-3813-3111
Homepage URL
Email	n.nishikawa.ts@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Nihon Medi-Physics Co.,Ltd.

IRB Contact (For public release)
Organization	Juntendo University Hospital Clinical Research and Trial Center
Address	3-1-3,Hongo,Bunkyo-ku,Tokyo
Tel	03-3814-5672
Email	hongo-rinri@juntendo.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	E22-0046
Org. issuing International ID_1	Juntendo University Hospital Clinical Research and Trial Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 05 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
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	Open public recruiting
Date of protocol fixation	2022 Year 04 Month 16 Day
Date of IRB	2022 Year 05 Month 20 Day
Anticipated trial start date	2022 Year 05 Month 25 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Amyloid PET will be performed in patients with PDD and DLB who have undergone or will undergo a detailed clinical evaluation to determine how beta-amyloid deposition in the brain affects the disease status

Management information
Registered date	2022 Year 05 Month 31 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054613