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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000023296

Enrollment

13350

Registered

2016-07-23

Start date

2016-07-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy elderly adults with poor cognitive performance

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactSangyoon Lee

National Center for Geriatrics and Gerontology Section of Cohort Study for Longevity, Department of Preventive Gerontology

sylee@ncgg.go.jp0562-45-5638

Outcome results