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

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FDA approves controversial new Alzheimer's drug tested in clinical trials in Indianapolis

INDIANAPOLIS – For the first time in decades, the Food and Drug Administration approved a new drug to treat Alzheimer’s patients. Some of the clinical trials were conducted in Indianapolis at JWM Neurology.

“In a normal clinical trial, there is one arm that receives a placebo, one arm that receives one dose of the drug, one arm that receives another dose, and a third arm that receives the highest dose. That way they can see if there is a dose response, ”explains Dr. Cindi McGarvey from JWM Neurology.

The drug was developed by Biogen and will be called Aduhelm. It brings hope to the patient, but not without controversy. Researchers believe that the formation of amyloid plaques in the brain can affect the severity of Alzheimer’s disease. The drug is designed to reduce the amount of these plaques. Dr. McGarvey says the drug manufacturers only succeeded in one of the studies and with the highest doses of the drug. The problem is that they have not been able to repeat the success in other attempts.

“The FDA went with it and approved it because it could be the beginning of a research method that might help, even if this drug isn’t the last one they end up with,” explains Dr. McGarvey. “I’d really like to see some repetition and data.”

The doctor said the drug was expensive and monthly IV fluids could cost about $ 50,000 a year without Medicare or insurance. She says patients also had side effects in clinical trials.

“In this study, around 40% of the patients had brain swelling that had to be followed up by a doctor,” explains Dr. McGarvey.

For Alzheimer’s advocates, they see hope with the new drug. Pat Armstrong is an advocate for the Alzheimer’s Association. She lost her mother, Dorothy, along with several other family members to Alzheimer’s. Her mother was diagnosed in the 1990s when she was 67 years old. Armstrong says there was only one drug back then to slow the progression of the disease. For them, the risk is worth every possible reward.

“Absolutely, without it she won’t get better, if she doesn’t get better with it, then what do we lose?” Asks Armstrong: “It’s not a cure. It is supposed to delay the progression. When I heard about this drug and thought that if I had been with my mother a little longer before her illness subsided, I would have given anything for this drug. “

Both Armstrong and Dr. McGarvey continues to hope that FDA approval of the drug will entice more companies into searching for cures.

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