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Fact check: What are the current FDA-approved medications for Alzheimer's disease treatment?
Executive Summary
FDA-approved treatments for Alzheimer disease include longstanding symptomatic drugs—donepezil, rivastigmine, galantamine, and memantine—plus several agents approved more recently that target amyloid: lecanemab and, in some sources, donanemab and aducanumab; additional approvals address behavioral and sleep symptoms such as brexpiprazole and suvorexant. The literature through 2025 emphasizes a shift toward disease-targeting biologics while retaining symptomatic therapies as standard care [1] [2] [3].
1. What the source analyses actually claim — a quick inventory of assertions
The provided analyses collectively claim that the FDA has approved classic symptomatic agents—cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine for cognitive symptoms—alongside anti-amyloid monoclonal antibodies including lecanemab and aducanumab, with at least one analysis also naming donanemab as an FDA-approved anti-amyloid therapy. They further state that brexpiprazole is approved for agitation associated with Alzheimer disease and suvorexant for insomnia in mild-to-moderate AD, while noting ongoing clinical-trial activity and biomarker use in trial design [1] [4] [2] [3] [5].
2. Consensus across reviews: symptomatic drugs remain the backbone of care
All reviews agree on the continued central role of cholinesterase inhibitors and memantine for symptomatic management of cognitive and functional decline in Alzheimer disease. These agents are presented as standard-of-care for mild to severe dementia, used to ameliorate cognitive symptoms rather than alter disease biology. The sources stress clinicians must weigh availability, adherence, cost, and individual patient risk–benefit when prescribing these drugs, highlighting persistent practical considerations in real-world treatment [1] [6].
3. The new class: anti-amyloid immunotherapies and divergent naming
Multiple analyses describe a recent shift toward amyloid-lowering monoclonal antibodies. Lecanemab is consistently named as an FDA-approved agent shown to slow cognitive decline in early-stage AD. Some analyses include aducanumab as an FDA-approved anti-amyloid drug; others list donanemab among approved therapies. This variation reflects differing emphases in the reviews and evolving approval/emergent-use pathways discussed in literature spanning 2023–2025, underlining heterogeneity in reported approval status across sources [2] [3] [1].
4. Timing and sources: why publication date matters for reported approvals
The evidence base spans 2023–2025, and the lists of approved drugs vary accordingly. Reviews dated 2023 and 2024 summarize the earlier approvals and symptomatic-agent landscape, while 2025 updates incorporate more recent trial results and regulatory actions highlighting lecanemab and donanemab as clinically important disease-targeting therapies. The publication dates explain some discrepancies: newer reviews report additional monoclonal antibodies and broaden discussion of biomarker-guided use compared with older primers [4] [2] [5].
5. Safety, efficacy, and who benefits — what the analyses emphasize
Analyses highlight that disease-modifying antibodies reduce amyloid burden and can slow decline in early-stage AD, but they also emphasize safety considerations, patient selection, and the importance of biomarkers for eligibility. One review notes biomarkers are used in the majority of contemporary trials (57%), reflecting a move toward targeting patients most likely to benefit. Authors caution clinicians to balance modest clinical benefits against risks such as amyloid-related imaging abnormalities and to consider individualized risk–benefit decisions [2] [5] [6].
6. Behavioral and sleep symptom approvals often overlooked but clinically relevant
Beyond cognition, reviews note FDA approvals for agents addressing behavioral and sleep disturbances common in Alzheimer disease. Brexpiprazole is cited for agitation associated with AD and suvorexant for insomnia in mild-to-moderate AD, illustrating that FDA approvals include symptom-specific psychiatric or sleep agents alongside cognitive and disease-targeting drugs. Clinical guidance stresses integrating these options into comprehensive symptom management while monitoring safety in older adults [3] [4] [6].
7. Pipeline context: many candidates but repurposed agents remain prominent
A 2025 pipeline review documents 182 clinical trials evaluating 138 candidate treatments, with substantial focus on biologics and small molecules. Approximately one-third of the pipeline comprises repurposed drugs, and the growing use of biomarkers in trial eligibility signals a methodological shift in how therapies are tested. This broad R&D activity frames current FDA approvals as early steps in a rapidly evolving therapeutic landscape that still faces efficacy, safety, and accessibility challenges [5].
8. Bottom line for clinicians and patients: what to take away now
Synthesize the analyses into a practical takeaway: symptomatic cholinesterase inhibitors and memantine remain core FDA-approved treatments, several anti-amyloid monoclonal antibodies (notably lecanemab, with differing mentions of aducanumab and donanemab across sources) represent the newer, disease-targeting approvals, and brexpiprazole and suvorexant address behavioral and sleep symptoms. Decision-making should incorporate publication timing, biomarker use, safety profiles, and patient-specific goals, as reflected across the 2023–2025 literature [1] [2] [3] [5].