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:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT06221202
Eligibility Criteria:
Criteria:
Inclusion Criteria (person living with dementia):
* age 50 or older
* a self-reported mild cognitive impairment or dementia diagnosis and mild-moderate dementia severity (confirmed by care partner or collateral)
* a care partner or a collateral (a family member, paid caregiver, or close friend who spends at least 8 hours/week with the person living with dementia and speaks fluent English) who consents to join the study
* English fluency, categorized as not requiring translation into another language. Being non-verbal or having limited verbal ability will not be considered exclusion criteria but this condition will be noted.
* access to and basic ability to use the videoconferencing platform (Zoom) on a digital device (tablet, telephone or computer) (or access to support therein).
Inclusion criteria (care partner or a collateral - defined as a family member, paid caregiver, or close friend who spends at least 8 hours/week with the person living with dementia):
* age 18 and older
* speaks fluent English
* access to and basic ability to use the videoconferencing platform (Zoom) on a digital device (tablet, telephone or computer) (or access to support therein).
Exclusion Criteria (person living with dementia):
* Persons living with dementia unable to provide consent or assent. Persons living with dementia who do not have capacity to provide consent but are capable of providing assent will be included if a care partner or collateral who is a legally authorized representative provides consent.
* Persons living with dementia with severe dementia (classified as being unable to sit up independently and being non-ambulatory within the upper extremities) will be excluded. Being non-verbal or having limited verbal ability will not be considered exclusion criteria but this condition will be noted. For these participants, attempts will be made to capture responses to questionnaires via alternative communication methods (gesture, facial expression, typing in the chat) and the care partner or collateral will be asked to corroborate or supplement the responses.
* Lack of reliable access to a digital device with Zoom application.
Exclusion criteria (care partner or a collateral):
• Lack of reliable access to a digital device with Zoom application.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06221202
Study Brief:
Protocol Section:
NCT06221202