Want FDA to weigh willingness of people with MCI/mild Alzheimer’s to take a disease-modifying therapy

Washington, D.C. (January 28, 2021) – A new UsAgainstAlzheimer’s A-LIST® survey shows that about eight in 10 people in the early stages of Alzheimer’s disease hope to have access to a treatment, if approved by the Food and Drug Administration, that would allow them to experience an additional year without worsening symptoms, even if there is a chance of side effects requiring close management by a physician.  

The survey, fielded January 15-19, found that 78 percent of those diagnosed with mild cognitive impairment (MCI) or mild Alzheimer’s disease (AD) considered it important to have access to a treatment that would give them a year without worsening symptoms, even if there is a chance of side effects requiring close management by a physician. In addition, 87 percent of those at significant risk for MCI, Alzheimer’s or another dementia said it was important to have access. 

The survey also found that 84 percent of people with MCI/Mild AD want the FDA to moderately or heavily factor the willingness of patients to take a potential Alzheimer’s treatment into the agency’s approval decision. Eighty-five percent of those at risk for MCI, Alzheimer’s or another dementia also want the FDA to consider patient willingness. 

The survey results come as the FDA is reviewing an application for aducanumab, a drug therapy designed to slow the progression of the disease in people with MCI and mild Alzheimer’s. 

In a letter to the FDA, UsAgainstAlzheimer’s urged the agency to approve aducanumab and consider the preferences of people who would benefit the most from what would be the first disease-modifying therapy for the treatment of Alzheimer’s disease. 

“Every single day of delayed progression of their disease matters,” UsAgainstAlzheimer’s wrote in its letter, signed by George Vradenburg, chairman and co-founder, and Russ Paulsen, chief operating officer. “We want and deserve to make a personal risk/benefit decision together with our physicians and should not, with this set of facts, have this choice taken from us.”

Asked what a disease-modifying therapy would mean to them, survey respondents indicated they would value highly the opportunity to maintain their current state of daily functioning for one year. Sixty-three percent of people living with a diagnosis say they would find significant or some benefits, as would 76 percent of caregivers of loved ones with these conditions, and87 percent of those at risk for MCI, Alzheimer’s or another dementia.   

More than half (55 percent) of respondents at risk for Alzheimer’s said that the availability of a drug to slow the progression of MCI/Mild AD would prompt them to seek earlier diagnosis, and 83 percent would consult a doctor to learn about their personal risk. 

In its letter, UsAgainstAlzheimer’s said the FDA should approve aducanumab, to give patients the opportunity to benefit now, with continuing studies to learn more details on the effectiveness of the drug: “We urge the FDA to approve aducanumab and put in place a platform to assess the real-world experience with the drug by persons in the early stages of Alzheimer’s disease. We note that the FDA has considerable discretion in making this decision, and that it regularly exercises this discretion in favor of approval of early therapies for other diseases. People staring into the abyss of Alzheimer’s deserve no less.

“Post-marketing collection of real-world evidence will help us all understand the effectiveness and safety of aducanumab, and we stand ready to support any such efforts,” the letter said. “Our spouses, parents, friends, and neighbors with mild cognitive impairment and mild Alzheimer’s are seeing their disease progress every day. Every day they lose is a day they will never get back. We need a first-in-class drug before we can have any hope of a best-in-class drug.” 

Survey Methodology: The survey, taken January 15-19, 2021 by the UsAgainstAlzheimer’s A-LIST®, had 751 responses overall from people living with Alzheimer’s or another dementia, current and former caregivers, people with a significant likelihood of developing the disease, and those interested in brain health. Of the total respondents, 705 described their status: 218 were individuals who are at risk for MCI/Alzheimer’s, 158 former caregivers, 149 current caregivers, 121 with a general interest in brain health, and 59 individuals with a diagnosis of MCI or Alzheimer’s.   Of those with a diagnosis of MCI/Mild Alzheimer’s, 41 answered the full set of questions. Of the caregivers, 34 indicated that their loved one had MCI or Mild Alzheimer’s.  This research is overseen by the Advarra Institutional Review Board.

###

About UsAgainstAlzheimer’s

UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the diseaseWe will not rest until brain-span equals lifespan - for everyone.