People with mild cognitive impairment are the target of an Alzheimer’s drug.

Alzheimer’s Drug Targets People With Mild Cognitive Impairment. What Does…




The approval of Aduhelm, a controversial new Alzheimer’s disease treatment, has brought attention to mild cognitive impairment, or impairments with memory, concentration, language, or other cognitive activities that go beyond typical aging changes.

After initially stating that Aduhelm could be provided to anyone with dementia, the Food and Drug Administration has now stated that the medication should only be given to people who have moderate cognitive impairment or early-stage Alzheimer’s disease.

However, this more limited proposal raises concerns. What does it mean to be diagnosed with mild cognitive impairment? Is Aduhelm suitable for all or just some people with moderate cognitive impairment? Dementia experts or primary care physicians should decide which patients are eligible for treatment.

Aduhelm is controversial since its efficacy has yet to be proven, its cost is considerable (an estimated $56,000 per year, not counting imaging and monthly infusions), and its possible adverse effects are severe (41 percent of patients in clinical studies reported brain swelling and bleeding).

Furthermore, an FDA advisory council vehemently opposed Aduhelm’s approval, and Congress is looking into the FDA’s decision-making process. Medicare is considering whether or not to cover the drug, and the Department of Veterans Affairs has declined to do so in most cases.

People over the age of 85, those on blood thinners, those who had had a stroke, and those with cardiovascular disease, poor kidney or liver function, among other disorders, were excluded from clinical studies for Aduhelm. According to a new research article published in the Journal of the American Medical Association, if those criteria were applied generally, 85 percent of persons with mild cognitive impairment would be unable to use the medicine.

Given these factors, carefully choosing patients with moderate cognitive impairment who might react to Aduhelm is “becoming a priority,” according to Dr. Kenneth Langa, a University of Michigan professor of medicine, health management, and policy.

“One of the main concerns we’ve been dealing with since Aduhelm’s approval is, ‘Are appropriate individuals going to be given this drug?’” said Dr. Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Disease Research Center.

Based on a review of research studies and talks with prominent experts, here’s what individuals should know about moderate cognitive impairment.

Basics.

Mild cognitive impairment is frequently referred to as a situation on the cusp between dementia and normal cognition. However, this can be deceiving. Many persons with moderate cognitive impairment do not develop dementia — mainly Alzheimer’s disease — despite the fact that a considerable number of them do.

Cognitive symptoms, such as difficulty with short-term memory or planning, are frequently modest, but they persist and indicate a drop in performance from previous levels. Despite this, a person with the disease may continue to work or drive and appear completely normal. Mild cognitive impairment, by definition, leaves a person’s capacity to do daily tasks independently intact.

Mild cognitive impairment affects almost 7% of adults aged 60 to 64, 10% of those aged 70 to 74, and 25% of those aged 80 to 84, according to an American Academy of Neurology assessment of dozens of research published in 2018.

Causes.

Mild cognitive impairment can be caused by biological processes connected to Alzheimer’s disease, such as the accumulation of amyloid beta and tau proteins and structural abnormalities in the brain. According to a 2019 research, between 40% and 60% of persons with mild cognitive impairment had indications of Alzheimer’s-related brain pathology.

Other variables that can produce cognitive symptoms include minor strokes, poorly controlled illnesses like diabetes, depression, and sleep apnea, pharmaceutical reactions, thyroid disease, and undiagnosed hearing loss. Normal cognition may be restored or further decline prevented if these concerns are addressed.

Subtypes. Experts have identified four categories of mild cognitive impairment within the last decade. Each subtype appears to have a varied chance of developing Alzheimer’s disease, but exact figures have yet to be determined.

People with memory problems and other medical disorders who have alterations in their brain discovered by imaging testing are likely to be the most vulnerable. “If biomarker tests show abnormalities in amyloid, tau, and neurodegeneration, you can be pretty sure a person with MCI has the beginnings of Alzheimer’s disease in their brain, and that disease will continue to evolve,” said Dr. Howard Chertkow, chairperson for cognitive neurology and innovation at Baycrest, an academic health sciences center in Toronto that specializes in care for older adults.

Diagnosis. This process usually starts when older people complain to their doctors that “something is wrong with my memory or thinking” – a so-called subjective cognitive complaint. Short cognitive tests can help determine whether there is objective evidence of impairment. Other tests can be used to see if a person is still capable of performing daily tasks.

If there is a need to better determine the level of impairment or if the results are ambiguous, more advanced neuropsychological testing may be beneficial. However, according to Kathryn Phillips, director of health services research and health economics at the University of California-San Francisco School of Pharmacy, “there is a shortage of physicians with expertise in dementia — neurologists, geriatricians, geriatric psychiatrists” — who can conduct comprehensive evaluations.

The most crucial step is to take a thorough medical history that notes whether an individual’s functioning has declined from their baseline and investigate possible explanations such as sleep habits, mental health issues, and poor treatment of chronic disorders that require attention.

Mild cognitive dysfunction “isn’t always easy to spot since people’s thinking and memory change over time [as they become older], and the question becomes, ‘Is this something more than that?’” Dr. Zoe Arvanitakis, a neurologist and head of the Rush Memory Clinic at Rush University in Chicago, agreed.

To rule out the potential that someone fared poorly because they were frightened, sleep-deprived, or having a bad day, more than one set of tests is required. Langa explained that “giving people exams over time can do a pretty decent job of determining who is genuinely decreasing and who isn’t.”

Progression.

Mild cognitive impairment does not always lead to dementia, and it usually does not happen quickly. This, however, is not fully understood. And progression estimates differ depending on whether patients are seen in speciality dementia clinics or community medical clinics, as well as how long they are followed.

According to an analysis of 41 research, 5% of patients treated in community settings develop dementia each year. The percentage was 10% for those seen in dementia clinics – typically, people with more serious symptoms. Following a review by the American Academy of Neurology, 15 percent of patients were found to have dementia after two years.

The path to dementia isn’t the only one individuals take. Further testing reveals that a large percentage of patients with mild cognitive impairment — anything from 14 percent to 38 percent — have normal cognition. Another part of the equation remains constant over time. (This could be because underlying risk factors have been addressed in both situations, such as poor sleep or poorly controlled diabetes or thyroid disease.) Another group of patients goes through phases of improvement and decline, with periods of stability in between.

Dr. Oscar Lopez, director of the University of Pittsburgh’s Alzheimer’s Disease Research Center, stated, “You really need to follow patients over time — for up to 10 years — to have a sense of what’s going on with them.”

Specialists versus generalists.

Experts agreed that Aduhelm should only be explored for those with mild cognitive impairment associated with Alzheimer’s disease. “Do I have MCI [mild cognitive impairment] owing to Alzheimer’s disease?” is the question you should ask your doctor. Chertkow explained.

Because this medicine targets amyloid, a sticky protein that is a characteristic of Alzheimer’s disease, a PET scan or spinal tap should be performed to confirm amyloid accumulation. However, the presence of amyloid in the brain isn’t always indicative: one-third of older persons with normal cognition have amyloid deposits in their brains.

Because of this complexity, Petersen of the Mayo Clinic believes that “for the early launch of a sophisticated medicine like this, care should be managed by specialists, at least initially.” Rush University’s Arvanitakis agreed. “At this time, if someone is sincerely interested in trying this medicine, I would urge that they do it under the supervision of a psychiatrist, neurologist, or someone who specializes in cognition,” she said.

We’d want to hear from readers with any queries they have, problems they’ve had with their care, or advice they need in dealing with the health-care system. To submit your suggestions or tips, go to khn.org/columnists.




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