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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036297
Receipt No. R000041332
Scientific Title PADNI: Parkinson's and Alzheimer's disease Dimensional Neuroimaging Initiative
Date of disclosure of the study information 2019/03/26
Last modified on 2019/03/26

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Basic information
Public title PADNI: Parkinson's and Alzheimer's disease Dimensional Neuroimaging Initiative
Acronym PADNI: Parkinson's and Alzheimer's disease Dimensional Neuroimaging Initiative
Scientific Title PADNI: Parkinson's and Alzheimer's disease Dimensional Neuroimaging Initiative
Scientific Title:Acronym PADNI: Parkinson's and Alzheimer's disease Dimensional Neuroimaging Initiative
Region
Japan

Condition
Condition Alzheimer's disease (AD), Parkinson's disease (PD) and AD/PD related disorders
Classification by specialty
Neurology Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We are aiming at creating an MRI database consisting of more than 1,000 elderly people including patients with AD spectrum disorders such as MCI, PD spectrum disorders, and healthy subjects. The database will include results of psychological testing, biomarkers such as blood and spinal fluid, and PET/SPECT images in addition to MRI. We hope to classify latent pathophysiologic backgrounds of elderly people with a new perspective. We will try to identify neural circuits, which are similarly or differentially involved in pathophysiology of the PD spectrum and the AD spectrum. In particular, we will be focusing on analyzing the process in which healthy elderly people develop neurodegenerative diseases including AD and PD spectrum disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of neural network functions and brain structures by means of MRI analysis, especially from the viewpoints of the PADNI concept, putting emphasis on chronological changes of the measures and their differences across groups.
Key secondary outcomes 1. Transition rate from preclinical AD to MCI or AD
2. Transition rate from prodromal PD/DLB to PD or DLB
3. Changes of biomarkers including blood and cerebrospinal fluid
4. Changes of amyloid accumulation in amyloid PET
5. SBR of DAT-SPECT and statistical index of image analysis
6. Clinical index: Correlation between each group or correlation between MRI evaluation index and clinical indicators in each group
7. If a participant dies during the study, we will consider an autopsy.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 This is an observational cohort study. There is no intervention. But we will perform this research in comliance with the level of invasive research with intervention.
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

Not applicable
Gender Male and Female
Key inclusion criteria All participants should fulfill the followings:
1) 50 years old or older, regardless of gender
2) Essentially, the participants themselves must understand the contents of the research, and a written informed consent should be obtained by their own free will. But, if a participant may not have the consent ability due to cognitive decline, we will obtain a written consent from a representative such as a study partner.
3) The participant should agree with on-schedule visits and clinical examinations.
4) Clinical examinations should not reveal abnormalities such as malignancies that may interfere with ongoing research participation.
5) Visual acuity, hearing and writing ability are maintained to the extent that they do not affect cognitive function tests.
6) Participants agree with invasive examinations including DAT-SPECT, amyloid PET, lumbar puncture and blood collection.
7) The participant has an informant (study partner). Study partners live at home, are healthy, have contact with participants for more than 10 hours a week, and the same study partner can accompany all visits during the observation period.
Key exclusion criteria 1) Existence of significant diseases that may affect the central nervous system other than the target disease of this research, such as neurodegenerative diseases (other than AD/PD related diseases), severe cerebrovascular diseases, neuroimmune diseases, and head injuries.
2) Existence of significant MRI abnormalities, which may affect cognitive function.
3) Drug-induced parkinsonism is likely.
4) SWEDD (Scans Without Evidence of Dopaminergic Deficit).
5) Contraindications to MRI.
6) Hypersensitivity to tracers such as 18F-GE067 and 123I-FP-CIT.
7) Medical history of schizophrenia; major depressive disorder or bipolar disorder defined by DSM-IV within a year.
8) A history of alcoholism and drug dependence defined by DSM-IV within the past two years.
9) Severe mental symptoms that make it difficult to comply with the protocol within the past three months
10) Serious systemic disease or an unstable disease.
11) Systemic disease affecting cognitive function such as infectious disease and metabolic disease.
12)Participant admitted to a nursing home or another hospital.
13) If a participant is planning to participate in a clinical intervention trial at the time of enrollment.
14) Any case in which a researcher or consulting doctor judges that the study is not appropriate for a particular participant.
Target sample size 672

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Hanakawa
Organization Natinal Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code 187-8551
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL 042-346-2206
Email hanakawa@ncnp.go.jp

Public contact
Name of contact person
1st name Mayumi
Middle name
Last name Inoue
Organization Natinal Center of Neurology and Psychiatry
Division name Integrative Brain Imaging Center
Zip code 187-8551
Address 4-1-1 Ogawahigashi, Kodaira, Tokyo
TEL 042-341-2712-7715
Homepage URL
Email mainoue@ncnp.go.jp

Sponsor
Institute Natinal Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center of Neurology and Psychiatry Clinical Research Review Board
Address 4-1-1 Ogawa-Higashi, Kodaira,Tokyo 187-8551, Japan
Tel 042-341-2712-7828
Email rinri-jimu@ncnp.go.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
2019 Year 03 Month 26 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 18 Day
Date of IRB
2018 Year 11 Month 07 Day
Anticipated trial start date
2019 Year 04 Month 01 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

Management information
Registered date
2019 Year 03 Month 26 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041332

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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