Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT03455569
Eligibility Criteria:
Inclusion Criteria for Alzheimer's disease (AD) patients:
* AD diagnosis OR probable or possible AD as documented in electronic medical record, which includes Mini Mental State Exam score \>12 (indicating mild to moderate severity of AD) and neuroimaging evidence
* Community-dwelling
* \>1 sleep problem \>3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale
* Aged \>60 years
* Able to ambulate with or without assistive device
* Have an eligible caregiver (see below)
Inclusion Criteria for caregivers:
* Live with an eligible patient
* Aged \>21 years
* Have regularly assisted patient with \>1 of 6 basic activities of daily living (ADLs) (i.e., bathing, dressing, toileting, transfers, continence, feeding) or \>1 of 8 Instrumental ADL (IADLs) (i.e., using the telephone, shopping, preparing meals, housekeeping, laundry, transportation, taking medicine, managing money) for the past 6 months
* Pittsburgh Sleep Quality Index (PSQI) total score \>5
* Montreal Cognitive Assessment (MoCA) score \>= 23
* Can communicate in English
Exclusion Criteria:
\- If AD patient is bed bound
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT03455569
Study Brief:
Protocol Section:
NCT03455569