Alzheimer’s disease is quite a common condition in the U.S.—over six million Americans are currently living with Alzheimer’s. Unfortunately, mortality from the disease has increased a staggering 145% between 2000 and 2019. An early diagnosis of symptoms and starting treatment early can delay the progression of Alzheimer’s disease. Slowing down progression while cognitive impairment is mild can delay the onset of dementia. Doing so can improve or maintain quality of life (QOL) for both patient and caregiver.
IDENTIFY THE PROGRESSION OF ALZHEIMER’S EARLY
Knowing what to look for makes one more likely to identify the signs and symptoms of cognitive decline. Early-interventions could provide a better handle on the person’s condition, extending the time wherein optimal QOL can be maintained. It affords time to finalize legal, financial, and care options, discuss wishes with family and develop an advance directive. Early detection also has the potential to reduce health care costs as it pushes back the need for expensive nursing home care.
On the flip side, a diagnosis of Alzheimer’s disease may be associated with fear, anxiety, anger, and despair. Misconceptions also delay early diagnosis: like memory problems being a normal part of aging, and that Alzheimer’s is not fatal. Early diagnosis could have other ramifications, however, such as impeding a person’s independence, their ability to drive or to continue working.
Impact of Caring for an Alzheimer’s Patient
According to the Alzheimer’s Association, there are over 11 million unpaid caregivers looking after those with Alzheimer’s disease or dementia. These are typically the person’s spouse or another family member. The long duration of the disease can place a huge strain on family caregivers. An early diagnosis—and potentially early treatment—can be a big help. It can give caregivers time to adjust to their loved one’s mood, personality, and functional changes before the progression of Alzheimer’s takes over.
The Alzheimer’s Association has developed a detailed document (here). It explains the value of early detection for the patient, family, health care system, and society as a whole.
A New Early-Intervention Drug Was Recently Approved
Aducanumab (brand name, Aduhelm), a new treatment designed to slow down cognitive and functional decline in early stages of Alzheimer’s disease, was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on June 7, 2021. Clinical information on this treatment was first submitted in July 2020 and the FDA granted the drug a Priority Review. Priority Review means the review process would be completed within six months instead of the standard ten months. However, in January 2021, the FDA extended the review period by an additional three months. Furthermore, they required the drug manufacturer to submit additional analyses and clinical data.
CONTROVERSY OVER APPROVAL
The approval has met with resistance. Results from the drug’s trials (called ENGAGE and EMERGE) have been controversial. After ending all aducanumab trials in early 2019 because the drug was thought to have failed to slow down cognitive decline, the drug developers dug deeper into the data and declared that the drug was indeed effective in specific groups of trial participants. An FDA Advisory Committee voted to not approve the drug and advised conducting an additional Phase 3 trial.
The Alzheimer’s Association disputed the need for a Phase 3 trial and requested the FDA approve the drug and monitor its performance through Phase 4 post-marketing studies. In their letter to the FDA, the Association asked FDA to weigh the uncertainty of the trial results against the “certainty of what the disease will do to millions of Americans absent a treatment.”
this episode of the Patients Rising Podcast
talks about Aducanumab and the arguments
made against it by economists.
The Bad Math That Hurts Patient Access – Patients Rising Podcast
OPTIONS AGAINST THE PROGRESSION OF ALZHEIMER’S
Acknowledging the global attention from all stakeholders that this approval process received, the FDA released a statement saying, “At the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward.”
“This is the first FDA-approved drug that delays decline due to Alzheimer’s disease” said Harry Johns, president and CEO of the Alzheimer’s Association. “This means individuals may have more time to actively participate in daily life, have sustained independence and hold on to memories longer. We can experience longer — the relationships we hold most dear — our families and friends”.
Below are some ongoing trials for treating early-stage Alzheimer’s disease:
Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience, who brings her skills and knowledge to the health care communications world. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.