Improving Access to Care for Veterans With Memory Loss

NCT ID: NCT07117162

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-29

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ADRD Care Delivery Protocol

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

Group Type EXPERIMENTAL

ADRD Care Delivery Protocol

Intervention Type OTHER

1\. Included in arm/group descriptions

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ADRD Care Delivery Protocol

1\. Included in arm/group descriptions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.


* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Pittsburgh Healthcare System

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alison O'Donnell, DO, MPH

Role: CONTACT

412-522-3123

Julie Faieta, PhD

Role: CONTACT

Facility Contacts

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Alison O'Donnell, DO, MPH

Role: primary

412-522-3123

Julie Faieta, PhD

Role: backup

References

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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

Reference Type 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.

Reference Type BACKGROUND
PMID: 33865446 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 37459141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33720637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20530010 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31367165 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 38689398 (View on PubMed)

Other Identifiers

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1850695

Identifier Type: -

Identifier Source: org_study_id

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