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# Roche Alzheimer’s Drug Misses in 2 Phase 3 Studies
- URL: https://www.fdaweb.com/roche-alzheimers-drug-misses-in-2-phase-3-studies/
- Published: 2022-11-14T12:00:00.000Z
- Updated: 2026-09-14T18:06:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153189

Roche says results from two Phase 3 studies evaluating Alzheimer’s therapy gantenerumab were not statistically significant in slowing clinical decline. “Study participants treated with gantenerumab showed a slowing of clinical decline in GRADUATE I and GRADUATE II of -0.31 (p=0.0954), and -0.19 (p=0.2998) respectively from baseline score on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), however, neither was statistically significant,” the company says. “This represents a relative reduction in clinical decline of 8% in GRADUATE I and 6% in GRADUATE II compared with placebo.” It says the rating tool measures cognitive and functional change across six areas — memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.

The subcutaneously administered monoclonal antibody is designed to target and bind to aggregated forms of beta-amyloid, including oligomers, fibrils and plaques, and activate immune cells in the brain to clear amyloid plaque and prevent further accumulation, Roche says. It explains that the level of beta-amyloid removal, the protein that builds up to make plaque in the brain, was lower than expected.

Roche is planning to present topline findings from the studies at the 11/30 Clinical Trials on Alzheimer’s Disease Conference.