Amyloid Clearing Drugs
This category includes anti-amyloid monoclonal antibodies developed for early Alzheimer’s disease, with current FDA-approved examples including lecanemab and donanemab. Their role in the neurodegeneration landscape is important because they are among the clearest attempts to move from symptom management toward targeted disease modification in Alzheimer’s.
Biological Rationale
These drugs are based on the idea that amyloid-beta accumulation is an early driver or amplifier of Alzheimer’s pathology. By binding amyloid and promoting plaque clearance, they aim to reduce one of the hallmark pathological features of the disease and potentially slow downstream injury.
Evidence Strength
Strong
The category clearly shows biological activity because it reduces amyloid plaque burden, and some agents have shown modest slowing of decline in early symptomatic disease. That said, the benefit is not dramatic, and this is not the same as reversing disease or restoring lost function. Even though drugs like lecanemab and donanemab were tested in patients with early stage patients, they had modest effect indicating that by the time symptoms emerge a lot of damage has already been done. Potentially, although this has not been tested, they could have greater effects in presymptomatic patients with a causative gene mutation.
Limitations
These therapies are currently relevant mainly to early Alzheimer’s, not advanced disease. Before symptoms ever show up, there is already significant amyloid and tau buildup as well as inflammation, so by the time these drugs enter patients their effect may be limited. They also carry important safety and monitoring issues, especially amyloid-related imaging abnormalities (ARIA), and they require significant infrastructure such as infusion capacity and MRI follow-up.
Sources
- van Dyck, C. H., Swanson, C. J., Aisen, P., et al. (2023). Lecanemab in Early Alzheimer’s Disease.
- Sims, J. R., Zimmer, J. A., Evans, C. D., et al. (2023). Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial.
- Perneczky, R., et al. (2024). Anti-amyloid antibody treatments for Alzheimer’s disease.
- Alkhalifa, A. E., et al. (2025). Anti-Amyloid Monoclonal Antibodies for Alzheimer’s Disease.
- U.S. Food and Drug Administration. (2025). FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi.
- U.S. Food and Drug Administration. KISUNLA® (donanemab-azbt) Prescribing Information.
- U.S. Food and Drug Administration. LEQEMBI® (lecanemab-irmb) Prescribing Information.