Study Results
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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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-10-29
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
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.
ADRD Care Delivery Protocol
1\. Included in arm/group descriptions
Usual Care
Patients will undergo usual care with all evaluation and testing at the discretion of the specialist.
No interventions assigned to this group
Interventions
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ADRD Care Delivery Protocol
1\. Included in arm/group descriptions
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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VA Pittsburgh Healthcare System
FED
Responsible Party
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Locations
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VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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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
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.
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.2023.13239.
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.
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.
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.
2024 Alzheimer's disease facts and figures. Alzheimers Dement. 2024 May;20(5):3708-3821. doi: 10.1002/alz.13809. Epub 2024 Apr 30.
Other Identifiers
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1850695
Identifier Type: -
Identifier Source: org_study_id
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