Phase 3 Trials of Gantenerumab Likely to Decide Clinical Benefit, Roche Says in Interview

Phase 3 Trials of Gantenerumab Likely to Decide Clinical Benefit, Roche Says in Interview
Roche soon will start two Phase 3 trials testing gantenerumab, its amyloid-targeting treatment candidate, in prodromal, or early, Alzheimer’s patients. Each plans to enroll 750 people, ages 50 to 90, and will judge gantenerumab’s effectiveness and potential clinical benefit by looking at changes in dementia and amyloid plaque load in the brain. The Phase 3 trials — GRADUATE1 (NCT03444870) and GRADUATE2 (NCT03443973) — will run for two years and be conducted at sites across the U.S, Canada, Europe, South America, Australia, and Asia. “We haven't published an exact date, but we're definitely about to start these studies soon,” Rachelle Doody, MD, Roche’s global head of Neurodegeneration, said in an interview with Alzheimer’s News Today. Patients will receive monthly, subcutaneous (under the skin) doses of gantenerumab, which will be titrated, or gradually increased, every three months. “The most important thing to realize about this titration is that it's the same for all patients, regardless of their APOE genotype,” Doody said. The combination of the two APOE gene copies determines the APOE genotype, a well-known risk factor for Alzheimer’s. The studies will be highly similar — same treatment, dosing, and outcome measures — to comply with US. Food and Drug Administration requirements that study results be replicated to ens
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    Perhaps somebody should tell them that “Insanity is repeating the same mistakes and expecting different results”. It could be very helpful in their drug development efforts.

  2. Dan White says:

    As long as all these intellectual giants living off Alzheimer’s research grants and publishing academic papers continue to be richly rewarded for their total lack of results, the same old results are adequate, status quo. Performance is evaluated by one’s ability to attract research dollars, not actual success. In any other line of work, these folks would starve to death! Why do they keep making the same mistakes over and over for decades? Because they continue to be rewarded quite well for it. The big Alzheimer’s gurus publish papers, make TV appearances, etc., yet they have ZERO meaningful results, other than making a grand living off the misery of others.

    For Big Pharma execs it’s all about money. Meanwhile, why rush a new drug while they can still maximize their dollar recovery on Aricept, Namenda and Exelon, all of which are much to do about nothing! And lest I forget, the only new drug released in recent years, Namzeric! Simply Aricept and Namenda combined.

    The system is broken. My heart truly breaks for all of us that are dealing with this disease at a personal level. Science and medicine have failed us repeatedly. Something must change quickly or this cruelest of diseases will be forgotten in the grand scheme of things.

    New “out of the box” approaches to funding, economic reward structure, hypothesis of Alzheimer’s causes, treatment options besides merely chasing beta amyloid, clinical trials, FDA approval, etc. are desperately needed!

    As the previous post said, insanity as an approach is never going to work!

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