Alzheimer’s disease is complex, and it is therefore unlikely that any one drug or other intervention will ever successfully treat it in all people living with the disease. Still, in recent years, scientists have made tremendous progress in better understanding Alzheimer’s and related dementias and in developing and testing new treatments.
Patients with Alzheimer’s disease have a build-up of a particular protein, amyloid-beta, in their brains. This leads to the degeneration of neurons. There are a number of drugs being tested in large-scale clinical trials that selectively target these amyloid-beta plaques called monoclonal antibodies.
On June 7, 2021, the FDA provided accelerated approval for the monoclonal antibody, Aduhelm. Aduhelm has not yet been shown to affect clinical symptoms or outcomes, such as the progression of cognitive decline or dementia.
On January 6, 2023, the FDA approved the monoclonal antibody Leqembi, also through its Accelerated Approval pathway. A study showed that lecanemab slowed cognitive decline in people with early-stage Alzheimer’s disease but at the risk of adverse side effects. The drug was fully approved on July 6, 2023.
Read more about Leqembi, Aduhelm, and donanemab below and watch a recording of the PMC Community Discussion on Anti-Amyloid Treatments for Alzheimer’s Disease:
According to a research study published on November 29, 2022, the experimental drug lecanemab was found to slow cognitive decline in people with early-stage Alzheimer’s disease but at the risk of adverse side effects.
In a study of 1,800 participants, lecanemab slowed cognitive decline by 27% compared with a placebo. Participants receiving the drug were more likely to experience brain bleeding and swelling than those receiving the placebo.
“The benefit is real; so too are the risks,” said PMC Co-Director Dr. Jason Karlawish.
Leqembi was approved by the FDA on January 6, 2023 using its Accelerated Approval Pathway program. This program allows the FDA to approve drugs that could be “potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.”
On July 6, 2023, the FDA fully approved the drug.
Read more about lecanemab:
- There’s finally a fully approved Alzheimer’s drug – but getting it won’t be easy, TIME
- Alzheimer’s drug Leqembi gets full FDA approval. Medicare coverage will likely follow, NPR
- FDA grants accelerated approval for Alzheimer’s disease treatment FDA.gov
- FDA gives green light to Leqembi, aka lecanemab Alzforum
- Dr. Karlawish answers common questions about Leqembi SciLine
- Dr. Karlawish warns of lecanemab safety concerns Science
- Alzheimer’s drug shows modest success slowing declines in memory, thinking, NPR
- The science behind lecanemab, BioArtic AB
The full results of the Phase 3 TRAILBLAZER-ALZ 2 study showed that the drug donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s.
On NPR’s 1A, Penn Memory Center (PMC) Co-Director Jason Karlawish, MD, said the results are “significant” and, when combined with the recent approval of the Alzheimer’s drug Leqembi, mark a “potentially revolutionary” era in Alzheimer’s research and clinical care.
Read more about donanemab:
- Treating Alzheimer’s Very Early Offers Better Hope of Slowing Decline, Study Finds, New York Times
- Positive donanemab study results may be ‘inflection point for the field’, Penn Memory Center
Aduhelm (aducanumab) is a drug developed by Boston-based biotechnology company Biogen. Studies show that aducanumab does not stop or reverse Alzheimer’s disease but may slow progression.
On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) released a decision for Medicare coverage of Aduhelm. CMS will cover Aduhelm under coverage with evidence development (CED). This means Aduhelm is covered for those who are participating in clinical trials.
After discussing the risks and uncertainties, physicians at the Penn Memory Center will prescribe Aduhelm to patients and families who are interested and eligible to receive it.
Read more about Aduhelm:
- Seeking maximum profits, Biogen set an ‘unjustifiably high price’ for Alzheimer’s treatment, investigation finds STAT+
- FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation STAT+