UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047904 |
|---|---|
| Receipt number | R000054613 |
| 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) |
| Date of disclosure of the study information | 2022/05/31 |
| Last modified on | 2022/05/31 17:45:09 |
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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
Interventions/Control_6
Interventions/Control_7
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
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
n.nishikawa.ts@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054613
