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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT06619327
Eligibility Criteria:
Inclusion Criteria:
* Recent (\~3 month) chart documented ADRD diagnosis,
* ADRD symptom onset after age 65
* Cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
* Cognitive awareness of their problems (as determined by the treating neurologist), and ability to understand study and research protocol, as determined by a standardized teach-back method assessment
Additional inclusion criteria for dyads are:
* English speaking adults (18 years or older)
* Dyad lives together
* At least one partner endorses clinically significant emotional distress during screening (\>7 on Hospital Anxiety and Depression scale subscales or \<5 on the Geriatric Depression Scale)
Exclusion Criteria:
* Patient is deemed inappropriate by the neurology team
* Either partner has a co-occurring terminal illness
* Patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06619327
Study Brief:
Protocol Section:
NCT06619327