Genentech : Alzheimer's Prevention Initiative Study Of Crenezumab Didn't Show Clinical Benefit

Genentech, in its update on alzheimer's prevention initiative study evaluating crenezumab in autosomal dominant alzheimer's disease, said Thursday that the investigational medicine did not slow or prevent cognitive decline in people with a specific genetic mutation which causes early-onset Alzheimer's disease.

"We're disappointed that the treatment did not demonstrate a statistically significant clinical benefit," said Eric Reiman, Banner Alzheimer's Institute executive director and one of the study leaders.

Roche Group's (RHHBY) Genentech noted that the trial did not demonstrate a statistically significant clinical benefit in either of its co-primary endpoints assessing the rate of change in cognitive abilities or episodic memory function, measured by the Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) composite cognitive score and the Free and Cued Selective Reminding Test Cueing Index, respectively.

According to the company, small numerical differences favoring crenezumab were observed across the co-primary and multiple secondary and exploratory endpoints, but those were not statistically significant. No new safety issues were identified with crenezumab during the study. Further analyses of data are ongoing.

The company will present initial data at the Alzheimer's Association International Conference on August 2, 2022.

The trial enrolled 252 people who are members of the world's largest extended family with ADAD in Colombia, with 94% of participants completing the study. Two-thirds of participants carried the Presenilin 1 E280A mutation which typically causes cognitive impairment due to Alzheimer's disease around age 44. Participants were randomized to receive crenezumab, an investigational treatment discovered by AC Immune SA, or placebo over five to eight years.

Genentech stated that it is also evaluating the potential of gantenerumab in autosomal dominant Alzheimer's disease, as well as for the prevention of sporadic Alzheimer's and treatment of early Alzheimer's in late stage clinical trials. Results from the phase III GRADUATE studies of gantenerumab in early Alzheimer's are expected in the fourth quarter of 2022.

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