What is anti-amyloid therapy for Alzheimer’s disease?


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What role does amyloid play in Alzheimer’s disease?

“Over a century ago, Dr. Alois Alzheimer described changes in the brain of a young woman who died of what is now called Alzheimer’s disease,” explains neurologist Dan Merman, M.D. “The hallmark changes were amyloid plaques and neurofibrillary tangles, which have been the focus of Alzheimer’s disease research ever since.”

Amyloid is a protein aggregate called beta-amyloid that accumulates in the brains of older people. This is one of the hallmark brain changes of Alzheimer’s disease. Scientists don’t know exactly what role amyloid plays in Alzheimer’s disease. It appears that amyloid can damage or be toxic to nerve cells.

Amyloid levels are not a good indicator of the severity of memory loss or the stage of Alzheimer’s disease. However, they appear to be important markers for the onset of disease progression. Amyloid buildup begins about 15 years before a person becomes amnesiac. By the time amnesia occurs, the amount of amyloid in the brain can be quite high and not change much thereafter.

How does anti-amyloid therapy work?

Anti-amyloid treatments work by attaching to and removing from the brain beta-amyloid, a protein that accumulates in plaques. Each drug works differently and targets beta-amyloid at different stages of plaque formation.

These drugs have not been proven to stop progression or improve cognitive function. But by clearing out amyloid plaques, these drugs seem to slow the brain changes in the early stages of Alzheimer’s disease by about 30 percent in a 18-month trial.

“The benefits of anti-amyloid therapy may increase over time,” says Dr. Merman. “Some studies suggest that it may be possible to keep people in such a mild stage of the disease for years. But we need more information to prove it.”

Aducanumab

The anti-amyloid antibody drug aducanumab (Aduhelm®) is the first drug in its class to receive early Food and Drug Administration approval based on its ability to clear amyloid plaques seen on brain scans. This treatment was studied in people with mild cognitive impairment due to Alzheimer’s disease or mild dementia and evidence of amyloid plaque accumulation in the brain. This drug is given monthly as an infusion.

Lecanemab

Lecanemab (Leqembi™) is an intravenous infusion of anti-amyloid antibodies with confirmed beta-amyloid elevations and accelerated FDA approval for the treatment of early Alzheimer’s disease. It works by attaching to and removing beta-amyloid in the brain. This drug is approved for patients with early Alzheimer’s disease. Candidates for this treatment must also have documented increased beta-amyloid plaques in the brain. This drug is given as an infusion every 2 weeks.

Donamab

Donanemab is an investigational biologic agent to treat the early symptoms of Alzheimer’s disease. Positive results have been shown in previously reported Phase 2 trials. Like other treatments, it works by removing beta-amyloid from the brain. It is administered to patients through monthly infusion therapy.

None of these drugs are currently covered by Medicare, Medicaid, or private insurance. However, if one or more of these drugs receives full FDA approval, insurance companies will reconsider coverage at that time. A doctor should be consulted to develop a treatment plan that is right for you, including weighing the benefits and risks of all approved treatments.

Who are candidates for anti-amyloid therapy?

New anti-amyloid drugs are approved for two groups of people: those with mild cognitive impairment and those with mild dementia due to Alzheimer’s disease. Recent studies suggest that removing amyloid slows the decline in memory tests and daily functioning.

As people progress to the later stages of dementia, some of these brain changes continue with or without the presence of amyloid plaques. This means that removing amyloid does not help patients with more advanced stages of the disease. Those patients continue to progress without significant change even after the amyloid is removed.

What are the risks? Is there anyone who should not use these drugs?

The most commonly reported serious side effects of anti-amyloid therapy are infusion-related reactions and amyloid-related imaging abnormalities. This common side effect usually causes no symptoms but can be serious. This is usually a microscopic bleed on a brain scan or temporary swelling of an area of ​​the brain that usually resolves over time.

Patients must be able to tolerate brain MRI scans before these treatments can begin. Therefore, people who are claustrophobic or wear a pacemaker are not candidates for this treatment. This is because anti-amyloid therapy requires regular MRI scans to check for microscopic bleeding or swelling that may result from treatment.

Patients also cannot use strong blood thinners such as Coumadin® or Eliquis® because of the increased risk of bleeding. Patients should be biomarker-confirmed for amyloid plaque pathology before starting any of these agents. This can be done by an amyloid PET scan or an examination of spinal fluid obtained by a lumbar puncture, which is not currently covered by insurance.

Where should I go if I am interested in new anti-amyloid treatments?

Currently, anti-amyloid therapy is only available to patients participating in clinical trials. If a drug gets full FDA approval, Medicare and other insurance companies may start paying for the treatment. It’s unclear when that will be, but some expect at least one of these drugs to receive full FDA approval in 2023.

Neurology, geriatrics, and geriatric psychiatric health care providers in Nebraska are available to discuss options with patients who may be eligible for this treatment.phone 800.922.0000 for scheduling.



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