UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023296
Receipt number R000026844
Scientific Title Organized Registration for the Assessment of dementia for Nationwide General consortium toward Effective treatments in Japan: ORANGE - Preclinical AD
Date of disclosure of the study information 2016/07/23
Last modified on 2021/01/28 17:04:43

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Basic information

Public title

Organized Registration for the Assessment of dementia for Nationwide
General consortium toward Effective treatments in Japan: ORANGE - Preclinical AD

Acronym

ORANGE - Preclinical AD study

Scientific Title

Organized Registration for the Assessment of dementia for Nationwide
General consortium toward Effective treatments in Japan: ORANGE - Preclinical AD

Scientific Title:Acronym

ORANGE - Preclinical AD study

Region

Japan


Condition

Condition

Healthy elderly adults with poor cognitive performance

Classification by specialty

Medicine in general Neurology Geriatrics
Psychiatry Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The ORANGE studies are aimed at establishing an organized and dynamic registration system that collects time-based information based on age and disease stages (the ORANGE platform) by monitoring the entire clinical course of patients with dementia, including Alzheimer's Disease (AD).

Basic objectives2

Others

Basic objectives -Others

The aim of ORANGE-Preclinical AD (cohort study) is to construct a registration system that collects information of healthy and preclinical participants, which contributes to the promotion of preventive research against dementia incidence.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Survival analysis is performed to determine the consequence of mild cognitive impairment (MCI) and dementia diagnoses. Other methods are added in order to search for an optimal statistical method.

Key secondary outcomes

To determine the reliability and validity of the system to assess the relationships among cognitive ability examination, MCI detection, lifestyle, and the types of clinic information in healthy elderly individuals. In addition, to use the results of the prospective study to determine the reliability and validity of the preclinical AD or MCI, which is obtained from the system, thereby, accelerating the process of MCI registry.


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Elderly adults who have participated
in cohort studies, 2) Native speaker who is healthy, preclinical, and with mild cognitive impairment (MCI), 3) Mini-mental state examination (MMSE) score 24 and over, 4) participants who sign the approved informed written consent form, 5) no limitations on age, sex, and medications.

Key exclusion criteria

1) MCI, dementia with Lewy bodies,
frontotemporal lobe dementia, Parkinson's disease, stroke, Huntington's disease, normal-pressure hydrocephalus, brain tumors, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, epilepsy, subdural hematoma, encephalitis / meningitis, multiple sclerosis, and brain injury with decline cognitive, 2) any local lesion such as cerebral infarction(s) detected by computed tomography (CT) or magnetic resonance imaging (MRI) before enrollment that can greatly affect cognitive function, 3) history of major depression, bipolar disorder, schizophrenia, and alcohol/drug abuse; and current serious or unstable disease, 4) inability to undergo cognitive tests, 5) patients deemed ineligible for enrollment by the lead principal investigator or co-researcher at each institution.

Target sample size

13350


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Shimada

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Preventive Gerontology

Zip code

474-8511

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture

TEL

0562-44-5651

Email

shimada@ncgg.go.jp


Public contact

Name of contact person

1st name Sangyoon
Middle name
Last name Lee

Organization

National Center for Geriatrics and Gerontology

Division name

Section of Cohort Study for Longevity, Department of Preventive Gerontology

Zip code

474-8511

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture

TEL

0562-45-5638

Homepage URL


Email

sylee@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Geriatrics and Gerontology

Address

7-430 Morioka-cho, Obu City, Aichi Prefecture

Tel

0562-44-5651

Email

yaday@ncgg.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

国立研究開発法人国立長寿医療研究センター


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 23 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

2015 Year 11 Month 02 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 22 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The ORANGE studies are aimed at establishing an organized and dynamic registration system that collects time-based information based on age and disease stages (the ORANGE platform) by monitoring the entire clinical course of patients with dementia, including Alzheimer's Disease (AD).The aim of ORANGE-Preclinical AD (cohort study) is to construct a registration system that collects information of healthy and preclinical participants, which contributes to the promotion of preventive research against dementia incidence.


Management information

Registered date

2016 Year 07 Month 22 Day

Last modified on

2021 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026844


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name