Recruiting NCT07117162
Improving Access to Care for Veterans With Memory Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADRD Care Delivery Protocol.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Increasing Access to Care: An Advanced Virtual Care Delivery Protocol to Deliver Diagnostic and Therapeutic Services to Underserved Veterans With ADRD
Overview
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.
Interventions
- Other ADRD Care Delivery Protocol
1\. Included in arm/group descriptions
Primary outcome measures
- 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.]
Secondary outcome measures (1)
- Number of Participants and Instances of Additional testing [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- VA Pittsburgh Healthcare System — Pittsburgh
Publications
- DONANEMAB-AZBT INJ,SOLN - VA Formulary Advisor. Accessed December 12, 2024. https://www.va.gov/formularyadvisor/drugs/4043274-DONANEMAB-AZBT-INJ-SOLN
- LECANEMAB-IRMB INJ,SOLN - VA Formulary Advisor. Accessed December 12, 2024. https://www.va.gov/formularyadvisor/drugs/4041980-LECANEMAB-IRMB-INJ-SOLN
- 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. PMID 37459141
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT07117162 · 1850695