UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036297
Receipt number 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 2023/03/29 11:11:39

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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

615


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

https://padni.org/

Email

mainoue@ncnp.go.jp


Sponsor or person

Institute

Natinal Center of Neurology and Psychiatry

Institute

Department

Personal name



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

Open public recruiting

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

2023 Year 03 Month 29 Day



Link to view the page

Value
https://center6.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