Mild Cognitive Impairment (MCI) due to Alzheimer disease or Alzheimer-type dementia
Conditions
Interventions
None listed
Sponsors
Tomita Kiyoyuki
Eligibility
Inclusion criteria
Inclusion criteria: Participants must meet all of the following conditions: 1 Care Recipient - Diagnosis of Mild Cognitive Impairment (MCI) due to Alzheimer disease or Alzheimer-type dementia, as determined by the investigator clinical judgment. - Age >= 65 years at the time of informed consent. - Ability to provide written informed consent for study participation. If the care recipient lacks decision-making capacity, written consent from a legally authorized representative is required. 2 Caregiver - Family member of the care recipient. - Provides in-home care for the care recipient for at least 1 hour per week, regardless of cohabitation status. - Ability to provide written informed consent for study participation.
Exclusion criteria
Exclusion criteria: Participants will be excluded if any of the following conditions apply: 1 Care Recipient - Hospitalized or institutionalized for more than one week. - Currently has, or has a history of, any condition other than Alzheimer disease that may cause dementia like symptoms, including: Major primary degenerative dementias other than AD (e.g., frontotemporal dementia). Vascular dementia or severe vascular cognitive impairment. Parkinson disease or Lewy body disease (e.g., Parkinson disease, dementia with Lewy bodies, Parkinson disease related dementia), as well as other major neurodegenerative disorders with motor impairment. Other neurological or psychiatric disorders that significantly affect cognition or activities of daily living (ADL), or are highly likely to do so (e.g., severe traumatic brain injury sequelae, severe intellectual disability, severe psychiatric disorders). History of cerebrovascular disease that significantly affects cognition or ADL, or is highly likely to do so (e.g., stroke, transient ischemic attack). Other major systemic diseases that may present dementia like symptoms (e.g., severe hypothyroidism, vitamin deficiency, brain tumor), except when deemed reversible at diagnosis. - No primary caregiver available. - Concurrent participation in an interventional trial. - Diagnosed with mixed dementia (Alzheimer disease combined with other dementias). - Presence of malignant tumors that are untreated following diagnosis or are treatment resistant. 2 Caregiver - Does not provide close, regular care for the care recipient (e.g., lives far away and the recipient lives alone). - Has been diagnosed with dementia. - Provides care for two or more care recipients, including those with conditions other than MCI due to AD or Alzheimer type dementia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Informal care costs for caregivers overall and stratified by Alzheimer disease severity | — |
Secondary
| Measure | Time frame |
|---|---|
| - Caregiver productivity loss (WPAI) - Caregiver quality of life (EQ-5D-5L) - Caregiver burden (ZBI) | — |
Contacts
Public ContactMayaka Tani
Eisai Co., Ltd.
Outcome results
None listed