Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE-Mild cognitive impairment (ORANGE-MCI)

Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE Organized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan: ORANGE-Mild cognitive impairment (ORANGE-MCI) - ORANGE-MCI study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021272

Enrollment

1500

Registered

2016-03-01

Start date

2016-03-01

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

Mild cognitive impairment, Dementia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with MCI (including early AD and other types of mild dementia) aged 40 years or older who speak Japanese as their mother tongue. Patients must have a Clinical Dementia Rating (CDR) of 0.5-1 and a Mini-Mental State Examination (MMSE) score of 20-30. 2. Patients accompanied by a co-participant (study partner). The study partner must be physically and mentally healthy, contact the patient about once a week, and know how the patient lives. Preferably, the study partner should be able to make many visits together with the patient during the monitoring period. 3. Patients and their study partners are able to give written informed consent 4. No limitations on age, sex, or concomitant drugs 5. All types of MCI

Exclusion criteria

Exclusion criteria: 1. Patients with a CDR of 2 or more or an MMSE score of 19 or less (including those with Alzheimer's disease, dementia with Lewy body, frontotemporal dementia, and vascular dementia). Those who meet this criterion will be eligible for another planned research protocol and are excluded from this program. Patients with the following conditions are also excluded: Parkinson's disease, apoplexy, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, epilepsy, subdural hematoma, encephalitis/meningitis, multiple sclerosis, or decreased cognitive function due to head injury. 2. Any local lesion such as cerebral infarction(s) detected by CT or MRI before enrollment that can greatly affect the cognitive function 3. History of major depression, bipolar disorder, schizophrenia, or alcohol/drug abuse; current serious or unstable disease 4. Patients unsuitable for treatment due to vitamin B1/B12 and/or folate deficiency, syphilis, or thyroid dysfunction 5. Inability to undergo CDR and MMSE tests 6. Patients deemed ineligible for enrollment by the responsible researcher or co-researcher at each institution

Design outcomes

Primary

Measure	Time frame
The Kaplan-Meier method will be mainly used to determine parameters such as when a patient progressed to dementia from MCI or first had a CDR of 2 or more or an MMSE of 19 or less, in accordance with the statistical analysis plan.	—

Secondary

Measure	Time frame
Other analyses such as subgroup analyses will also be performed in accordance with the statistical analysis plan. Meanwhile, based on the advancement in statistical analysis methods, improvements and additions will be accordingly added to the current methods overall so that the most appropriate analysis will be constantly performed.	—

Countries

Japan

Contacts

Public ContactTakashi Sakurai

National Center for Geriatrics and Gerontology Administrative Office of ORANGE Registry

orange-registry@ncgg.go.jp0562-46-2311(2390)

Outcome results