Older adults with cognitive impairment.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Subjects who 1) aged 65-85 at the time of enrollment. 2) have age-adjusted decline at least SD of 1.0 from the reference threshold in any cognitive domains measured by using NCGG-FAT. 3) have provided a written informed consent on this study and biobank project* by subjects. *: Only for subjects recruited from the NCGG.
Exclusion criteria
Exclusion criteria: Subjects who 1) are needed to restrict any physical exercise and/or diet due to functional decline, including presence of bone or joint disease, renal faiure, ischemic heart disease, and cardiopulmonary disorders. 2) are diagnosed with dementia. 3) have a MMSE score of less than 24. 4) are unable to speak in Japanese. 5) are unable to perform cognitive tests. 6) have a care-needs certification in the long-term care insurance system. 7) are deemed ineligible for enrollment by the responsible researcher or co-researcher at each institution.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in a composite score of cognitive function from baseline to a 18-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in a composite score of cognitive tests from baseline to a 6/12-month follow-up. 2) Changes in scores of each cognitive test from baseline to a 6/12/18-month follow-up. 3) Changes in laboratory and urinary markers from baseline to a 6/18-month follow-up. 4) Changes in ADL scores from baseline to a 6/18-month follow-up. 5) Changes in the status of frailty from baseline to a 6/18-month follow-up. 6) Changes in brain images assessed using MRI or CT from baseline to a 18-month follow-up. 7) Changes in the number of medications. 8) Changes in each result of a comprehensive geriatric assement from baseline to a 6/18-month follow-up. 9) Incident dementia. | — |
Countries
Japan
Contacts
National Center for Geriatrics and Gerontology Department of Geriatric Medicine