Reader TTS

Safety is also top of mind. The drug, a monoclonal antibody, has been shown to cause small bleeds and swelling in the brain, which means if it's approved and used by patients, periodic

MRI scans may be needed to monitor these side effects, explains Ronald Petersen, M.D., director of the Mayo Clinic's Alzheimer's Disease Research Center, who also consults for

Biogen. "We have huge hope that it could work, and people need hope,” says Sarah Lenz Lock, senior vice president for policy at AARP and executive director of the AARP-founded Global

Council on Brain Health (GCBH). “But it's really important for the FDA to play this very scientifically accurate. We're relying on the FDA to make a wise decision.” QUESTIONS ON

ACCESS AND AVAILABILITY EMERGE Beyond efficacy and safety, there are questions surrounding how easily patients will be able to access the drug if it is approved. Biogen's clinical trial

population was made up of people who had mild cognitive impairment and people with mild dementia due to Alzheimer's disease. So if aducanumab gets the green light from the FDA, the

drug will presumably be limited to patients who are in the beginning stages of Alzheimer's disease and who have evidence of amyloid in the brain. But early diagnosis is tricky. For

starters, there is no single test to determine whether someone has Alzheimer's disease. And most people aren't diagnosed by doctors until after signs of mental decline set in and

brain damage has already occurred, which may be too late. Expensive brain scans and spinal taps can identify amyloid in the brain before severe symptoms start, but “not everybody has access

to amyloid scans,” Isaacson points out. “They're FDA-approved, but they're oftentimes hard to get” and insurance may not cover the costs. Less invasive blood tests that physicians

can use to detect amyloid and other signs of Alzheimer's disease have proved promising in studies but are still at least a couple of years away from being widely available in doctors’

offices. "I'm not sure that our health care system and practitioners with boots on the ground are truly ready for this drug's approval,” Isaacson adds. “These logistical and

operational challenges are real.” Another thing to consider: Aducanumab is an infusion therapy, not a pill that can be popped at home. This means patients have to receive the medicine

intravenously, and, as Isaacson points out, memory clinics may not be equipped to deliver infusion drugs. Travel to these regular appointments will also need to be arranged, although this

will likely be less of a burden for people with early Alzheimer's, compared to individuals in later stages of the disease, says Sharon Cohen, M.D., medical director of the Toronto

Memory Program, who also served on the steering committee for aducanumab during its clinical trials. "In these early stages, people are very aware and very eager to hang on to their

abilities,” she explains. Many still work and are still able to carry out everyday activities. “Having been involved in the aducanumab program, the burden to patients and families coming in

for monthly infusions has been surprisingly well tolerated,” Cohen adds.