Improving Access to Care for Veterans With Memory Loss

NCT07117162 | Recruiting

• 1 other identifier: 1850695
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Time to Eligibility Determination

  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.

  From date of randomization until the date of determination of eligibility for monoclonal antibody therapy, assessed up to 12 months.

• Time to Initial Infusion

  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.

  From date of randomization until the date of first infusion, assessed up to 12 months.

Secondary Outcomes (1)

• Number of Participants and Instances of Additional testing

  1 year

Study Arms (2)

ADRD Care Delivery Protocol

EXPERIMENTAL

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

Other: ADRD Care Delivery Protocol

Usual Care

NO INTERVENTION

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

Interventions

ADRD Care Delivery Protocol OTHER

1\. Included in arm/group descriptions

ADRD Care Delivery Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of mild cognitive impairment or mild dementia due to suspected or confirmed AD with a 5 minute telephone MoCA score \>7

You may not qualify if:

• 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
• years and older
• Able to communicate in English
• Willing to give informed consent.
• None

Sponsors & Collaborators

• VA Pittsburgh Healthcare System: lead

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

Related Publications (9)

• DONANEMAB-AZBT INJ,SOLN - VA Formulary Advisor. Accessed December 12, 2024. https://www.va.gov/formularyadvisor/drugs/4043274-DONANEMAB-AZBT-INJ-SOLN

  BACKGROUND

• LECANEMAB-IRMB INJ,SOLN - VA Formulary Advisor. Accessed December 12, 2024. https://www.va.gov/formularyadvisor/drugs/4041980-LECANEMAB-IRMB-INJ-SOLN

  BACKGROUND

• Sims JR, Zimmer JA, Evans CD, Lu M, Ardayfio P, Sparks J, Wessels AM, Shcherbinin S, Wang H, Monkul Nery ES, Collins EC, Solomon P, Salloway S, Apostolova LG, Hansson O, Ritchie C, Brooks DA, Mintun M, Skovronsky DM; TRAILBLAZER-ALZ 2 Investigators. Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial. JAMA. 2023 Aug 8;330(6):512-527. doi: 10.1001/jama.2023.13239.

  PMID: 37459141 BACKGROUND

• Mintun MA, Lo AC, Duggan Evans C, Wessels AM, Ardayfio PA, Andersen SW, Shcherbinin S, Sparks J, Sims JR, Brys M, Apostolova LG, Salloway SP, Skovronsky DM. Donanemab in Early Alzheimer's Disease. N Engl J Med. 2021 May 6;384(18):1691-1704. doi: 10.1056/NEJMoa2100708. Epub 2021 Mar 13.

  PMID: 33720637 BACKGROUND

• Yaffe K, Vittinghoff E, Lindquist K, Barnes D, Covinsky KE, Neylan T, Kluse M, Marmar C. Posttraumatic stress disorder and risk of dementia among US veterans. Arch Gen Psychiatry. 2010 Jun;67(6):608-13. doi: 10.1001/archgenpsychiatry.2010.61.

  PMID: 20530010 BACKGROUND

• Walker LE, Poltavskiy E, Janak JC, Beyer CA, Stewart IJ, Howard JT. US Military Service and Racial/Ethnic Differences in Cardiovascular Disease: An Analysis of the 2011-2016 Behavioral Risk Factor Surveillance System. Ethn Dis. 2019 Jul 18;29(3):451-462. doi: 10.18865/ed.29.3.451. eCollection 2019 Summer.

  PMID: 31367165 BACKGROUND

• 2024 Alzheimer's disease facts and figures. Alzheimers Dement. 2024 May;20(5):3708-3821. doi: 10.1002/alz.13809. Epub 2024 Apr 30.

  PMID: 38689398 BACKGROUND

• VHA_ALZHEIMERS_DEMENTIA_Statistical_Projections_FY21_and_FY33_sgc121820.pdf. Accessed December 12, 2024. https://www.va.gov/GERIATRICS/docs/VHA_ALZHEIMERS_DEMENTIA_Statistical_Projections_FY21_and_FY33_sgc121820.pdf

  BACKGROUND

• Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Abeta protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. doi: 10.1186/s13195-021-00813-8.

  PMID: 33865446 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Alison O'Donnell, DO, MPH

CONTACT

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

Julie Faieta, PhD

CONTACT

juf52@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 12, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)