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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | No Intervention | Patients will undergo usual care with all evaluation and testing at the discretion of the specialist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADRD Care Delivery Protocol | Other | 1. Included in arm/group descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants and Instances of Additional testing | 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. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison O'Donnell, DO, MPH | Contact | 412-522-3123 | alison.odonnell2@va.gov | |
| Julie Faieta, PhD | Contact | juf52@pitt.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System | Recruiting | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 37459141 | 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. | |
| 33720637 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
| 20530010 | 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. |
| 31367165 | 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. |
| 38689398 | 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. |
| 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 |
| 33865446 | 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. |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |