Recruiting

ADRD Care Protocol

Sponsor:

VA Pittsburgh Healthcare System

Code:

NCT07117162

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADRD Care Delivery Protocol

Study Details

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.

Conditions

Alzheimer Disease

Study ID

NCT07117162

Start date

Oct 29, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Exclusion Criteria:

  • None

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: ADRD Care Delivery Protocol

Patients will undergo telehealth preparedness assessment, cognitive screening, and blood biomarker testing prior to the initial consultation with the specialist.

no intervention: Usual Care

Patients will undergo usual care with all evaluation and testing at the discretion of the specialist.

Interventions

ADRD Care Delivery Protocol

1\. Included in arm/group descriptions

Primary outcome measure

  • Time to Eligibility Determination [ Time Frame: From date of randomization until the date of determination of eligibility for monoclonal antibody therapy, assessed up to 12 months. ]
  • Time to Initial Infusion [ Time Frame: From date of randomization until the date of first infusion, assessed up to 12 months. ]

Central Contacts and Locations

Central contacts

Alison O'Donnell, DO, MPH

412-822-1020alison.odonnell2@va.gov

Julie Faieta, PhD

juf52@pitt.edu

Locations

VA Pittsburgh Healthcare System

Recruiting

Pittsburgh, Pennsylvania, United States, 15240

Contacts

Alison O'Donnell, DO, MPH

412-522-3123alison.odonnell2@va.gov

Julie Faieta, PhD

juf52@pitt.edu

Principal Investigator:

Alison O'Donnell, DO, MPH

More Information

Sponsor

VA Pittsburgh Healthcare System

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by VA Pittsburgh Healthcare System on 2026-07-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.