Alzheimer Disease
Conditions
Brief summary
This study evaluates a care delivery protocol to improve access to care for Veterans with Alzheimer's Disease and Related Disorders (ADRD). A randomized controlled trial will enroll Veterans with mild cognitive impairment or early dementia at VA Pittsburgh. The ADRD care delivery protocol integrates telehealth, advanced diagnostics, and streamlined workflows to expedite screening for eligibility for amyloid targeting therapies.
Interventions
OTHERADRD Care Delivery Protocol
1\. Included in arm/group descriptions
Sponsors
VA Pittsburgh Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild cognitive impairment or mild dementia due to suspected or confirmed AD with a 5 minute telephone MoCA score \>7 * Meets VA MUE inclusion/
Exclusion criteria
for mAb therapy for AD * Enrolled in VA care * Lives in a home setting (i.e., not in an institutional setting such as a nursing home, Community Living Center, or hospital) * Has a working telephone * 18 years and older * Able to communicate in English * Willing to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Eligibility Determination | From date of randomization until the date of determination of eligibility for monoclonal antibody therapy, assessed up to 12 months. | Compare the number of days from randomization to the determination of eligibility for monoclonal antibody therapy for both the intervention and usual care groups, assessed up to 12 months. |
| Time to Initial Infusion | From date of randomization until the date of first infusion, assessed up to 12 months. | Compare the number of days from the date of randomization to the initial infusion of monoclonal antibody therapy for both the intervention and usual care groups, assessed up to 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants and Instances of Additional testing | 1 year | Chart review will be used to determine the number of participants who underwent additional testing and the total number of additional tests performed. This includes counting instances of APOE genetic testing, MRI brain imaging, and amyloid PET imaging as ordered at the discretion of the specialist. |
Countries
United States
Contacts
CONTACTAlison O'Donnell, DO, MPH
CONTACTJulie Faieta, PhD
Outcome results
None listed