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New Alzheimer’s drug on verge of approval by FDA

If the FDA approves the treatment, it may take six months to a year before it would be available to patients.

CLEVELAND — In the next few days, the FDA will make one of the biggest moves in the fight against Alzheimer's disease.  It must decide whether to approve a controversial, first-of-its-kind medication that may help those in the early stages of dementia.  

"It slowed down the progression, we do not cure the disease or turn back time, so yes it will be a good medication for people on earliest stage of disease," says Dr. Babak Tousi of Cleveland Clinic. 

The monthly IV treatment, called aducanumab, removes amyloid plaque in the brain, a substance some believe leads to memory loss. The debate is whether the drug also improves cognitive ability.  

Ron and Colleetta DeChant understand the need for medical pioneers.  She's a nurse, he's a pharmacist.  Ron's memory began to wane a decade ago and in 2015 he signed on to test the drug. 

"We're hopeful, we have to have hope," Colleetta said. 

Critics say the trial data isn't enough to prove it works and the FDA shouldn't approve it. 

"There is more memory loss but I don't know what it would have been like if we hadn't started it, so we're in the optimistic group, if it doesn't help us it will help somebody," Colleetta said. 

Supporters admit the studies aren't perfect, but it may help some, and fast track research. 

"This has opened the door to a whole new way of treating and addressing Alzheimer's disease, and if it is approved it will be one of the first of many come down the road hopefully," Dr. Tousi said. 

It would also change the way Alzheimer's is diagnosed because in order to get the drug, there has to be evidence of amyloid plaque on the brain.  But even if it doesn't get approved, hope isn't lost. 

"We have three or four more in the pipeline that actually are more promising results, so keep in mind even if it's not approved, I wouldn't call it failure because we learned so much from it," Dr. Tousi said. 

We should know by Monday if the FDA will approve the drug. If that happens, it may take six months to a year before it would be available to patients.  

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