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NCT Number: NCT07117162

Improving Access to Care for Veterans With Memory Loss

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location status: Recruiting

Location contact

Alison O'Donnell, DO, MPH

CONTACT

[email protected]

412-522-3123

Alison O'Donnell, DO, MPH

PRINCIPAL_INVESTIGATOR

Julie Faieta, PhD

CONTACT

[email protected]

Julie Faieta, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADRD Care Delivery Protocol

Other
  • Included in arm/group descriptions

Primary outcomes

  1. 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.

    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.

  2. Time to Initial Infusion

    Time frame: 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 outcomes

  1. Number of Participants and Instances of Additional testing

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alison O'Donnell, DO, MPH

CONTACT

[email protected]

412-822-1020

Julie Faieta, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

VA Pittsburgh Healthcare System

Fed

Registry information

Official study title

Increasing Access to Care: An Advanced Virtual Care Delivery Protocol to Deliver Diagnostic and Therapeutic Services to Underserved Veterans With ADRD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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