Millions of Americans to get access to cutting-edge Alzheimer’s drug from this THURSDAY

Alzheimer’s patients across America are getting a glimmer of hope this week with health officials poised to approve a groundbreaking drug.

The monoclonal antibody therapy lecanemab is expected to be approved by the Food and Drug Administration (FDA) on Thursday, July 6.

The drug – which is administered intravenously – was shown in clinical trials to reduce the toxic buildup of clumps of toxic amyloid proteins in the brain, a hallmark of Alzheimer’s disease, and slow symptoms of the brutal memory-robbing disorder in patients with an early form. . of the disease by about a quarter – which in real terms equates to about six extra months of healthy living.

Despite the treatment’s great promise, it has the potential to cause serious and sometimes life-threatening side effects, including bleeding or swelling in the brain.

But the FDA’s expert panel of neurologists unanimously agreed that the benefits of the medication outweighed the small risk of adverse reactions, which affected one in seven trial participants.

The approval paves the way for more than a million Americans in the early stages of the disease to access Alzheimer’s treatment, possibly as early as summer’s end.

To be eligible for treatment, potential patients must undergo tests that show they are in the early stages of dementia.

Doctors will also need to determine if the patient’s brain contains amyloid deposits, usually by doing a PET scan.

The potential for the drug is huge — it’s estimated that more than six million Americans have Alzheimer’s disease, and of that total, between 360,000 and 640,000 have early-onset Alzheimer’s.

The drugmakers estimate much less people – 100,000 by 2026 – will actually get the drug because of health insurance barriers.

The actual number of patients who will access it is unclear, as providers will face a mountain of paperwork and bureaucratic hurdles to provide it.

It is also scheduled to become available to more than one million Alzheimer’s patients enrolled in Medicare, the government’s health insurance program that targets seniors age 65 and older.

While Medicare has said it will foot the bill for the $26,500 a year medication “in the right environment,” Medicare often doesn’t cover the additional costs for Alzheimer’s treatments that can run into the thousands of dollars.

Patients enrolled in Medicare could still be on the hook for portions of the cost of PET scans used to detect amyloid deposits, as well as repeat MRIs, tacking on an extra $5,000 per year on average. This would be a major hurdle for Medicare enrollees with median incomes around $31,000.

The late-stage clinical trial involved nearly 1,800 patients aged 50 to 90 years with mild cognitive impairment caused by Alzheimer’s disease or early-stage Alzheimer’s disease.

The participants were evaluated in several areas to determine the rate of cognitive decline, including memory and problem solving. Cognitive decline was measured using the clinical dementia classification, an 18-point scale where a higher score indicates a greater degree of disability.

The IV monoclonal antibody administered twice a month slowed the rate of cognitive decline by 27 percent, amounting to a delay of about six months.

The drug received accelerated FDA approval in January based on its ability to clear sticky amyloid plaques from the brain.

More than 6 million Americans have Alzheimer’s disease, and the vast majority of them are over the age of 65 and eligible for government insurance under Medicare.

In healthy people, those amyloid proteins are removed from the brain. In the context of Alzheimer’s disease, the deposits of amyloid beta proteins accumulate over time to form ‘sticky’ plaques in the brain that are thought to disrupt cell-to-cell communication and activate the immune system, causing inflammation occurs.

When the buildup of amyloid in the brain reaches a tipping point, it leads to the formation of tangles of a protein called tau.

The formation of these tangles disrupts the normal functioning of brain cells by interfering with the transport of essential molecules such as neurotransmitters involved in intercellular communication and nutrients such as glucose and oxygen.

Research into the exact mechanisms that cause Alzheimer’s disease is ongoing and far from complete. Some researchers believe that tau plays a bigger role than amyloid plaques in the progression of the disease.

Over time, the buildup of plaques and tau tangles damages synapses in critical brain regions, such as the hippocampus, for example, which is critical for forming memories, as well as the entorhinal cortex that relays sensory information from the outer cortex of the brain. to the hippocampus.

That buildup also damages the parietal lobe of the brain, which is intimately involved in sensory perception, spatial awareness, and the ability to sustain attention.

Despite the promise shown in studies, some experts are not convinced of the drug’s benefit. While one panel member, Dr. Merit Cudkowicz, called the clinical evidence “very clear” and “very robust,” others expressed concern about the significant health risks associated with the lab-made antibody.

Of those who received lecanemab during the study, 17 percent had brain hemorrhage, compared to nine percent in the placebo group, and 13 percent had brain swelling, compared to only two percent of those who received a placebo.

In a previous study, about seven percent of trial participants dropped out due to side effects, compared to less than three percent of placebo recipients.

Overall, 14 percent of people who received the drug experienced a serious side effect during the study, compared to only 11 percent of those who did not receive the drug.

The companies behind the drug, Eisai in Tokyo and Biogen in Cambridge, Massachusetts, have said 13 trial participants have died.

One of those participants was Florida native Genevieve Lane, 79, who suffered a massive, fatal seizure caused by a burst blood vessel in her brain in September 2022, just a week after her third dose of the drug.

Ms Lane’s daughter Julie said her mother was in the early stages of her illness and was considered suitable for the lecanemab trial.

But shortly after her first infusion, Genevieve’s health begins to decline slowly, then quickly. A week after the third infusion on September 7, she collapsed and was rushed to hospital, but there was little the doctors could do.

Five days after she was admitted, the family made the decision to remove Genevieve’s life support. She died on Sept. 19.

While neurologists have said the drug holds huge promise for millions of Americans, its rollout is expected to be bogged down by bureaucratic roadblocks. Under the federal guidelines, doctors will be required to participate in registries that collect evidence of how the drugs work in the real world.

Many doctors don’t see this requirement as onerous – collecting patient data is something they do every day.

But Alzheimer’s activists fear this will cause harmful delays in prescribing, depriving some patients of much-needed help. And with lecanemab, which is intended for people who show early signs of the disease, time is of the essence.

The approval also requires a deluge of paperwork, communication with insurers and the government, and the hiring of qualified workers to diagnose and treat Alzheimer’s disease. An aging population coincides with a rise in Alzheimer’s disease and related dementias, and the healthcare system is struggling to keep up.