Last year saw two new Alzheimer’s drugs hit the market — the anti-amyloid drug Leqembi, which may slow cognitive decline in the earliest stages of Alzheimer’s disease, and Rexulti, which reduces symptoms of agitation. Experts are predicting 2024 will be another pivotal year.

There’s a long list of Alzheimer’s drugs in the development pipeline. Some are designed to treat the disease’s symptoms. Others attempt to target the disease at its roots—cleaning protein plaques out of the brain or aiming to affect the immune system itself in order to slow Alzheimer’s progression. Two of them are due for an FDA decision this year. And pending the results of clinical trials, another two could enter the FDA review process.

DRUG DECISIONS EXPECTED IN 2024

Two companies filed for approval of their drug last year. If approved, these drugs may hit the market by the end of the year.

Alpha-1062 

Alpha Cognition’s Alpha-1062 is a new form of galantamine that leads to less unpleasant gastrointestinal side effects like diarrhea, nausea, and vomiting. After taking it as a pill, the liver activates the drug and then travels into the brain through the bloodstream, acting as a cholinesterase inhibitor. It prolongs the effects of the brain’s chemical signals to treat symptoms like memory loss.  

The clinical trial was not registered with the National U.S. clinical trial registry, and the data is not currently published in peer-reviewed journals. 

Donanemab

Donanemab is the next anti-amyloid monoclonal antibody up for regulatory review. The drug may slow the progression of Alzheimer’s disease in the earliest stages by helping clear beta-amyloid plaques in the brain.

In clinical trials, the drug slowed the progression of Alzheimer’s disease over the course of 18 months by a small amount, though not all clinicians are sure whether this is noticeable. About two in five patients who took the drug experienced amyloid-related imaging abnormalities (ARIA) — brain swelling or brain bleeds — and in most cases, these side effects were asymptomatic.

COMING ATTRACTIONS

These companies expect to receive results from their clinical trials later this year and intend to file approval afterward.

Alzheon’s ALZ-801 

ALZ-801 is a pill that prevents good forms of beta-amyloid from turning toxic and sticking together. It is currently being tested among patients with mild cognitive impairment or early Alzheimer’s who carry two copies of the APOE4 gene, which puts them at risk of brain bleeds and brain swelling from other drugs on the market like Leqembi.

The company expects to have results from its final clinical trial later this year and intends to file a new drug application by the end of 2024. The company is also actively testing the drug in other populations of patients with Alzheimer’s disease. 

Annovis Bio’s buntanetap 

Buntanetap is a pill that is being tested for treating mild and moderate forms of Alzheimer’s as well as other neurodegenerative diseases. It works by preventing cells from making toxic protein plaques which clump together. 

The results from its clinical trial are expected by April 2024, and afterward, the company will meet with the FDA to discuss filing for approval.