FDA approves controversial new Alzheimer’s drug that had clinical trials in Indianapolis


INDIANAPOLIS — For the first time in decades, the Food and Drug Administration has approved a new drug to treat Alzheimer’s patients. Part of the clinical trials were done in Indianapolis at JWM neurology.

“In a normal clinical trial, there is an arm that gets placebo, an arm that gets one dose of the drug, an arm that gets another dose, and a third one that gets the highest dose. This way they can see if there’s a dose response,” explains Dr. Cindi McGarvey with JWM neurology.

The drug was created by Biogen and will be called Aduhelm. It is bringing hope to patients, but not without controversy. Researchers believe amyloid plaque buildup in the brain can impact the severity of Alzheimer’s. The drug is supposed to decrease the amount of those plaques. Dr. McGarvey says the drug creators only found success in one of the trials, and with the highest doses of the drug. The problem is they were not able to repeat the success in other trials.

“FDA went along and gave approval of it because this may be the beginning of a research modality that might help, even if this drug isn’t the final one, they end up on,” explains Dr. McGarvey, “I would really like to see a little bit of repetition and data.”

The doctor went on to say the drug is expensive, and monthly infusions can cost roughly $50,000 annually without Medicare or insurance. She says clinical trial patients also showed side effects.

“In this trial, about 40% of the patients did show some brain swelling which would have to be followed by physician,” explains Dr. McGarvey.

For Alzheimer’s advocates, they are seeing hope with the new drug. Pat Armstrong is an advocate with the Alzheimer’s Association. She lost her mother Dorothy to Alzheimer’s along with several other family members. Her mother was diagnosed in the 1990s when she was 67. Armstrong says at the time there was only one drug to try and slow the progression of the illness. To her, the risk is worth any potential reward.

“Absolutely, she’s not going to get better without it, if she doesn’t get better with it, what are we losing?” questions Armstrong, “It is not a cure. It is to delay the progression. When I heard about this drug, and I thought if I had a little longer with my mother before her disease started declining, I would have given anything for that drug.”

Both Armstrong and Dr. McGarvey remain hopeful that the FDA approval of the drug will entice more companies to look for cures.

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