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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023296
Receipt No. 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 2016/07/22

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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
Middle name
Last name Hiroyuki Shimada
Organization National Center for Geriatrics and Gerontology
Division name Department of Preventive Gerontology
Zip code
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
Middle name
Last name Sangyoon Lee
Organization National Center for Geriatrics and Gerontology
Division name Section of Cohort Study for Longevity, Department of Preventive Gerontology
Zip code
Address 7-430 Morioka-cho, Obu City, Aichi Prefecture
TEL 0562-45-5638
Homepage URL
Email sylee@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Address
Tel
Email

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
2016 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.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


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