A proven treatment to slow down the progression of Alzheimer’s — a devastating disease that robs individuals of their personality, autonomy, and ultimately life — has long been out of reach.

But within the next year, Alzheimer’s patients could conceivably have access to not just one such treatment, but two.

This new era for Alzheimer’s treatment began this week, when the Food and Drug Administration (FDA) granted full approval to a new Alzheimer’s drug, lecanemab, which is being sold by its manufacturer Eisai under the brand name Leqembi. Memory clinics are already reporting increasing curiosity among patients about the new treatment, and they expect interest will only grow following the FDA’s final sign-off.

In the next few weeks, new clinical trial results are also expected for another treatment candidate, donanemab, which has had impressive preliminary results.

Just two years ago, the Alzheimer’s community was in turmoil. An earlier drug, called aducanemab and known by the brand name Aduhelm, had reported disappointing clinical trial results, but the FDA, over the objections of its scientific advisers, still decided to grant “accelerated approval” to the drug, which has a lower threshold for approval and is reserved for drugs that address an unmet need. The controversy cast a pall over the medication, Medicare severely limited coverage, and few prescriptions were written for a treatment once hoped to be a breakthrough.

People who work in the field describe a community at war with itself, as some advocacy groups pushed for more access to aducanemab even as many clinicians remained unconvinced.

Lecanemab could offer a fresh start. The clinical data appears more promising. The FDA’s advisers endorsed it last month. The preliminary results from donanemab appear even more impressive, though they need to be confirmed in forthcoming reports.

It is still a fraught moment for providers and patients. The treatments require an extensive patient evaluation before being prescribed, regular infusions in their administration, and careful monitoring over time to catch potentially dangerous side effects — all a challenge for the US health system. Not enough doctors are trained in caring for patients with memory problems. There are not enough infusion centres. Medicare covers some of the scans that could be used to identify patients who may benefit from lecanemab, but not others.

The logistical challenges could be daunting, said Sanjeev Vaishnavi, a clinical neurologist at the Penn Memory Center who is helping to lead its planning efforts. The centre sometimes has a months-long waiting list from patients who are seeking more specialised care than their primary care doctor is able to provide. If the demand for lecanemab is high, new patients could end up waiting for years — at which point, they may no longer benefit from the drug.

“I think the concern is, how can we deliver appropriate care to the right individuals in a timely manner?” Vaishnavi said, articulating his fear that patients could end up “stuck in a morass of bureaucracy”.

Nevertheless, he said, “it’s an exciting time.”

Alzheimer’s afflicts at least six million Americans. While only a subset may benefit from lecanemab, it holds enormous promise for those patients and their families — and for the many Alzheimer’s patients who will follow in the years to come, as the country’s population ages. This disease is distinct not only for its prevalence but also for the way it works. Over time, it wears away a person’s personality and sense of self. Ultimately, it is 100 per cent fatal.

Science has searched for an effective treatment; for decades, potential breakthroughs would show promise and then flame out. The failures led some researchers in recent years to question the entire premise of most Alzheimer’s research, though lecanemab may prove to be a kind of validation of the amyloid hypothesis that has driven drug development.

Jason Karlawish, the co-director at the Penn Memory Center, described his colleagues, patients, and their families as “travellers who finally see they arrived at land after traversing a dangerous ocean.”

“I’d much rather be in this place than where things were two or three years ago,” he told me. “This is what we’ve been waiting for for decades.”

This story first appeared on Vox.com. It was written by Dylan Scott who has covered health care for Vox. He has reported on health policy for more than 10 years, writing for Governing magazine, Talking Points Memo and STAT before joining Vox in 2017. Read more: https://www.vox.com/policy/2023/7/7/23784663/alzheimers-drug-lecanemab-leqembi-full-fda-approval