Rachelle Doody, MD, PhD: CREAD and GRADUATE trials for Alzheimer's

Two new Alzheimer’s disease (AD) therapies may be on the market soon, courtesy of Genentech alone.

In 4 different presentations at the 70^th annual meeting of the American Academy of Neurology (AAN) in Los Angeles, CA, this week, the biotechnology company reported promising results of crenezumab and gantenerumab investigational therapies for the treatment of AD.

Gantenerumab, a monoclonal antibody targeting the brain beta amyloid plaque in higher dosing regimens of 1200 mg, now has results showing significant reduction from phase 3, open-label extension studies. Data from these 2 studies guided the dose and titration regimen selection for the GRADUATE phase 3 pivotal program.

In crenezumab’s ongoing studies (CREAD), the antibody targeting amyloid beta oligomers has been specified to an optimal dosing regimen following the results of a phase 1B study in doses up to 120 mg, for the treatment of early AD.

In a conversation with MD Magazine, Rachelle Doody, MD, PhD, global head of Neurodegeneration for Genentech, said their current phase 3 pivotal trials for crenezumab are using a dosing regimen 4 times greater than previous studies.

“What we’re hoping to do is slow the clinical progression of prodromal to mild Alzheimer’s disease,” Doody said.

Doody said the AD field has settled on 2 pathophysiology trails — each of those targeted by crenezumab and gantenerumab. Though trials for the therapies started “early and low” for dosing and administration, they are reaching potential consideration for US Food and Drug Administration (FDA) marketing.

What’s left to prove is both therapies are safe and beneficial for patients at the currently set doses.

“That’s why we have 2 studies for each antibody: one to show there’s benefit and replicate that benefit, to hopefully lead to approval of these therapies for AD,” Doody said.

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For more extensive coverage from the Alzheimer’s disease space, check out MD Magazine's sister site, NeurologyLive. The Clinical Focus page serves as a resource for clinical news, articles, videos, and newly released data pertaining to dementia, too.

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