There may be two FDA-approved drugs to slow Alzheimer’s disease

A Phase 3 clinical trial of donamab enrolled 1,736 people with the following conditions: mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease.

MCI is an early form of memory loss or loss of other cognitive functions such as language and visual/spatial awareness. Some people with MCI show improvement in symptoms, which may be a precursor to Alzheimer’s disease.

Brain scans confirmed deposits of beta-amyloid and tau (another protein implicated in Alzheimer’s disease) in the brains of all clinical trial participants.

Participants were randomly assigned to receive either donamab or an inactive placebo. These were administered by intravenous infusion every 4 weeks for approximately 18 months.

The results showed that cognitive function and activities of daily living continued to decline in all participants during the study period.

However, the researchers found that the decline was delayed by about four months in patients who received donanemab.

When the researchers looked only at people with low or moderate levels of tau, they found that the decline was delayed by about eight months in those taking donanemab.

The study found that participants with high levels of tau got little or no benefit from the drug.

Additionally, those who took donemab were less likely to progress from MCI to mild dementia. That means moving from being completely independent in daily activities to requiring some support, the authors of a related paper said. Editor I have written.

They are also less likely to transition from mild dementia to moderate dementia, which requires some assistance with basic self-care, according to the editorial authors.

The results of the trial also showed that the drug has potentially life-threatening side effects.

Nearly 37% of those who received donanemab had brain swelling or bleeding, compared to 15% of those who received placebo. Most cases in the donanemab group were mild to moderate, but three participants died as a result.

Eli Lilly said so Submitted for FDA approval We are seeking approval for donemab and expect to hear from authorities before the end of the year.

of Phase 3 clinical trial Lecanemab also showed similar effects in people with MCI or mild dementia, slowing cognitive and daily functioning declines.

The drug was also associated with potentially life-threatening brain swelling and bleeding. As a result, the FDA has requested that her prescribing information for Leqembi include boxed warnings regarding these risks.

Doctor.Doug SharThe director of the Department of Cognitive Neurology at the Ohio State University Wexner Medical Center Neurological Institute said the “big news” about lecanemab and donanemab is that they not only improve people’s symptoms, but also change the course of the disease.

But he stressed that the clinical benefits seen during the first year and a half of treatment, or during Phase III trials of these drugs, were “modest.”

“The effect may be long-lasting, but we’ll have to wait and see,” he told Healthline.

However, both drugs significantly delayed the decline in cognition and daily functioning compared to the placebo group. Dr. Christian Camargoan assistant professor at the University of Miami Miller School of Medicine and a neurologist at UHealth, the University of Miami Health System.

For patients, this is a “time saver,” meaning they get additional time to function better, he told Healthline.

“If you need less help in your daily life and are able to enjoy conversations and activities, it’s likely a reflection of your quality of life,” Schaar says.

Doctor.Manisha PallekarThe co-director of the Center for Amnesia and Brain Health at Hackensack University Medical Center agreed.

With these drugs, she “will be able to remain functional for another six months without needing help from family or others,” she told Healthline. “This will help you live independently for an extended period of time.”

While the results of trials of these treatments are promising, Camargo noted that Alzheimer’s disease is highly complex.

“People often have multiple medical conditions, and proteins that accumulate and damage the brain as a result of Alzheimer’s tend to re-accumulate,” he said.

Given the complexity of the disease, Parlecard believes anti-amyloid drugs are unlikely to be the only treatment needed for Alzheimer’s disease.

Still, “this group of drugs gave us the next step,” she said. “But we have to keep building on these developments.”

Camargo said the decision to use these drugs remains a “very individualized and individual decision” and requires discussion between patients and doctors because of their modest efficacy and potential risk of serious side effects.

This requires consideration of the person’s genetic profile and other risk factors, he said.

Parlecar said the use of these drugs requires careful patient selection and ongoing monitoring for possible side effects such as brain swelling and bleeding.

In addition, she noted, these treatments work best in the early stages of the disease. Not designed for people with late stage mild, moderate or severe dementia.

Unfortunately, “often people may not go to the doctor early on,” she said. “Thus, by the time they seek a diagnosis, they are very likely to be in late or moderate stages of dementia.”

Schaal said health care providers need to have knowledge of how to diagnose Alzheimer’s disease in its early stages in order to improve treatment outcomes.

Also, “If you or a loved one notices changes in thinking or memory over the past year, they should contact their health care provider for evaluation,” he said.

Developed by Ohio State University self-administered test Designed to detect early signs of impairment in cognition, memory and thinking. This is free and can be taken at your home or provider’s office.

Camargo, who provides specialized dementia care to socioeconomically and racially diverse communities, said ensuring access to new treatments for Alzheimer’s disease was of particular interest.

However, many factors can limit the reach of these agents.

For example, in some multigenerational households in certain communities, older people continue to work to support their families, he said. As a result, regular visits to the clinic for IV infusions, monthly for donanemab and twice monthly for lekumbi, may be difficult.

They may also face other barriers to treatment, such as lack of a driver’s license, access to a car or public transportation.

Cost is another issue that can prevent certain people from getting these treatments.

The annual price for Lekembi is $26,500.Medicare reportedly agreed to reimburse the drug Kaiser Family Foundationbut 20% coinsurance payment. This equates to an out-of-pocket expense of over $5,000 each year.

This may be out of reach for some people with Medicare, especially Hispanic and Black seniors. high rate of dementia According to the KFF, they earn less than whites.

Furthermore, although the majority of people with Alzheimer’s disease are over the age of 65, preclinical cognitive changes and mild cognitive impairment can also occur in younger people, Parlecard said.

These people may not have Medicare, which is primarily for people over the age of 65.

Currently, the only other insurance that covers Rekumbi is the Veterans Administration program, Exclude people under the age of 65;

As a result, middle-aged and older people who may benefit from these new drugs may not have health insurance coverage or may be uninsured or underinsured.

“Unfortunately, this [lack of coverage for younger ages] It will have an impact on health equity and access to treatment for diverse populations,” Parlecar said.

For the first time, two drugs may soon be available that can help delay the symptoms of Alzheimer’s disease. Experts warn the benefits may be modest.