Improving Access to Care for Veterans With Memory Loss

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT07117162
• Lead Sponsor: VA Pittsburgh Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-25
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Diagnosis of mild cognitive impairment or mild dementia due to suspected or confirmed AD with a MoCA score >17
• 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.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Additional testing	1 year	Chart review will be used to determine what additional testing was ordered at the discretion of the specialist, including APOE genetic testing, MRI brain imaging, and amyloid PET imaging.

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States