AHEAD 3‐45 study design: A global study to evaluate the efficacy and safety of treatment with BAN2401 for 216 weeks in preclinical Alzheimer’s disease with intermediate amyloid (A3 trial) and elevated amyloid (A45 trial) Article Swipe
Paul Aisen
,
Jin Zhou
,
Michael C. Irizarry
,
Lynn D. Kramer
,
Chad J. Swanson
,
Shobha Dhadda
,
Martin Rabe
,
Stephen Krause
,
David Jianjun Li
,
Rema Raman
,
Michael Donohue
,
Gopalan Sethuraman
,
Keith A. Johnson
,
Reisa A. Sperling
·
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1002/alz.044511
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1002/alz.044511
Background Aβ pathologies occur years prior to cortical tauopathy, neurodegeneration, and clinical symptoms. BAN2401 is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to soluble Aβ aggregated species (oligomers, protofibrils). BAN2401 reduced amyloid on PET and slowed cognitive decline in a Phase 2 study in early symptomatic AD. The AHEAD 3‐45 study will test the safety and efficacy of BAN2401 even earlier in the AD continuum. Method AHEAD 3‐45 consists of two trials (A3 Trial and A45 Trial) under a single protocol and screening process, common schedule of assessments, and distinct dosing regimens tailored to the baseline amyloid level. The study is a Public‐Private Partnership of the Alzheimer’s Clinical Trial Consortium (ACTC), National Institutes of Health (NIH), and Eisai, Inc. The A3 Trial will enroll cognitively normal individuals (CN) with intermediate amyloid (approximately 20‐40 centiloids), at risk for further amyloid accumulation and development of neurofibrillary tangles on tau PET over four years. Approximately 400 participants will be randomized 1:1 to placebo or BAN2401 infusion—8 weeks of titration followed by 10 mg/kg every four weeks for 216 weeks. The A45 Trial will enroll CN individuals with elevated amyloid, defined as amyloid PET approximately >40 centiloids, at risk for cognitive decline over four years. Approximately 1000 participants will be randomized 1:1 to placebo or BAN2401 infusion—8 weeks of biweekly titration dosing, then 10 mg/kg biweekly induction dosing through 96 weeks to clear aggregated Ab, followed by 10 mg/kg every four weeks maintenance dosing through 216 weeks to prevent reaccumulation of Aβ. Result Longitudinal cognitive, safety, amyloid and tau PET, MRI and fluid biomarker assessments will be performed. The primary outcome of the A3 Trial is prevention of brain amyloid accumulation by amyloid PET at 216 weeks, with delay of tau PET accumulation as a key secondary outcome. The primary outcome measure of the A45 Trial is the Preclinical Alzheimer’s Disease Cognitive Composite 5 (PACC5) scale at 216 weeks. Conclusion The AHEAD 3‐45 Study will test whether BAN2401 can prevent the accumulation and spread of Aβ deposition, downstream tau pathology, and cognitive decline in at‐risk cognitively normal individuals prior to significant irreversible neurodegeneration.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1002/alz.044511
- https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/alz.044511
- OA Status
- bronze
- Cited By
- 20
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3112095771
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W3112095771Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1002/alz.044511Digital Object Identifier
- Title
-
AHEAD 3‐45 study design: A global study to evaluate the efficacy and safety of treatment with BAN2401 for 216 weeks in preclinical Alzheimer’s disease with intermediate amyloid (A3 trial) and elevated amyloid (A45 trial)Work title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2020Year of publication
- Publication date
-
2020-12-01Full publication date if available
- Authors
-
Paul Aisen, Jin Zhou, Michael C. Irizarry, Lynn D. Kramer, Chad J. Swanson, Shobha Dhadda, Martin Rabe, Stephen Krause, David Jianjun Li, Rema Raman, Michael Donohue, Gopalan Sethuraman, Keith A. Johnson, Reisa A. SperlingList of authors in order
- Landing page
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https://doi.org/10.1002/alz.044511Publisher landing page
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/alz.044511Direct link to full text PDF
- Open access
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YesWhether a free full text is available
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-
bronzeOpen access status per OpenAlex
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https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/alz.044511Direct OA link when available
- Concepts
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Dosing, Medicine, Placebo, Clinical trial, Cognitive decline, Tolerability, Internal medicine, Tauopathy, Amyloid (mycology), Randomized controlled trial, Oncology, Neurodegeneration, Pathology, Adverse effect, Disease, Dementia, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
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20Total citation count in OpenAlex
- Citations by year (recent)
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2025: 2, 2024: 1, 2023: 8, 2022: 7, 2021: 2Per-year citation counts (last 5 years)
- Related works (count)
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10Other works algorithmically related by OpenAlex
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