On Thursday, the Food and Drug Administration gave full approval to the drug Leqembi for patients who are in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the cost of the $26,500-a-year drug. The decisions by the two federal agencies will greatly increase access to the drug but will also present a dilemma for patients and their families.

There are many factors, both financial and medical, to weigh. Here are answers to some crucial questions:

Leqembi is not a cure for Alzheimer’s, and the drug does not improve patients’ memories or cognitive abilities. It also does not prevent the disease from getting worse. What Leqembi can do is modestly slow cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggested the drug can slow decline by about five months over an 18-month period for those patients.

How the drug might affect a patient’s daily life is likely to vary widely. For some people, Leqembi could mean several more months of being able to follow a prescription, balance a checkbook or perform other activities without help. For others, the effect might be much more subtle and hardly noticeable.

Yes. The drug can cause swelling or bleeding in the brain, which is often mild or moderate and resolves on its own but can be serious and in very rare cases can be fatal. The FDA is so concerned about these side effects that it requires a “black-box warning”—the most urgent level— on the label of the drugsaying that the drug can cause “serious and life-threatening events.”

Patients who are at higher risk include those who have blood thinners, those who have had more than four microscopic bleeds in the brain and those with an Alzheimer’s-linked gene mutation called APOE4 – especially if they have two copies of the mutation. They, along with their doctors, should consider whether the increased safety risk outweighs their desire for a drug that might modestly slow cognitive decline.

A large clinical trial of the drug found that nearly 13 percent of patients receiving Leqembi experienced brain swelling, but most of those cases were mild or moderate. Less than 2 percent of patients receiving the placebo experienced such swelling. Most brain swelling did not cause symptoms and generally resolved within a few months.

About 17 percent of the patients receiving Leqembi experienced a brain bleed, compared with 9 percent of patients receiving the placebo. The most common symptom of brain bleeds was dizziness, the study said.

Leqembi – which is administered by intravenous infusions in a doctor or clinic every two weeks – will be available to people diagnosed as having early-stage Alzheimer’s and to those with a pre-Alzheimer’s disease called mild cognitive impairment. About 1.5 million people in the United States fit that description. Another 5 million who have Alzheimer’s will not qualify for Leqembi because their disease has progressed too far.

The FDA-mandated label on the drug instructs doctors not to treat patients without testing to confirm they have one of the hallmarks of Alzheimer’s: a buildup in the brain of the protein amyloid that Leqembi attacks. Amyloid levels can be assessed with PET scans, spinal taps or newly available blood tests.

Most patients will be old enough for Medicare, which has said it will pay for 80 percent of the drug’s $26,500 annual cost. Patients would be left with about $6,600 in co-payments, which can put the drug out of financial reach for many. Some or all of that co-pay could be covered by the supplemental private insurance that many Medicare patients have.

However, there may be tens of thousands of dollars in additional costs – including medical visits for the infusions and regular brain scans. Some Alzheimer’s experts have estimated that the total cost of taking Leqembi could be approx $90,000 a year. With 80 percent coverage, treatment could potentially leave patients with $18,000 a year in out-of-pocket costs.

Talk to your doctor. If your doctor is not familiar with Alzheimer’s treatment, consider talking to a specialist. The most important thing is to discuss the decision with medical experts who will carefully explain the risks for your specific situation.

To learn those risks, request genetic testing to determine if you have the APOE4 gene mutation. People with two copies of that mutation — about 15 percent of Alzheimer’s patients — have a particularly high risk of brain swelling and bleeding.

There are also other factors to consider. Would going to a clinic for a drug infusion every other week be a burden?

And, importantly, how do you and your family perceive your current cognitive condition and how it affects your life? Because Leqembi is for people with mild symptoms, some people may be less inclined to take safety risks, but others might consider it especially important to try a drug that could keep them in this mild stage a little longer.

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