Roche Set to Start Two Phase 3 Trials of Gantenerumab in People with Early to Mild Alzheimer’s

Roche Set to Start Two Phase 3 Trials of Gantenerumab in People with Early to Mild Alzheimer’s
The safety and efficacy of Roche’s gantenerumab, a treatment candidate for Alzheimer’s, will be tested in two global Phase 3 clinical trials in patients with early to mild forms of the disease. The studies follow a long research process that defined the therapy's optimal dose. The GRADUATE1 (NCT03444870) and GRADUATE2 (NCT03443973) trials will both run for two years (104 weeks) and are set to start in July 2018. They will measure treatment effectiveness against placebo by looking changes in dementia severity at the trials' end. The company plans to enroll 750 patients, ages 50-90, in each trial at sites across the U.S, Europe, South America, Australia and Asia. Both will transition into open-label extension studies. Patients not wishing to continue in them will be followed for up to 50 weeks after the last gantenerumab dose. Gantenerumab is a fully human antibody that targets beta-amyloid, a protein that accumulates in neurons and is the main component of amyloid plaques found in the brains of Alzheimer’s patients. Potential benefits of treatment — given as under-the-skin injections — will be compared with placebo. Both studies will analyze effectiveness using the Clinical Dementia Rating Sum of Boxes (CDR-SB) scores, a global assessment tool that determines dementia severity. Scientists will also assess gantenerumab’s effects using other Alzheimer’s-related scale
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  1. maria damato says:

    my name is maria damato i live on long island in ny. i have been diagnosed with mild alzheimer’s disease i would like to join your study

    • Niklas Reich says:

      Dear Maria,

      As it is stated in the text above, Roche will run two clinical trials with gantenerumab: GRADUATE1 (NCT03444870) and GRADUATE2 (NCT03443973). These trials will probably start recruiting patients by the end of July 2018.

      If you want to participate, you should contact Roche via email: [email protected].
      When contacting them, you should state a Reference Study ID Number, depending on which trial you want to participate in –> for GRADUATE1, state “WN29922” as reference study ID Number and for GRADUATE2, state “WN39658”.
      I am not affiliated with Roche in any way, thus I cannot tell you if there is a major difference between GRADUATE1 and GRADUATE2. You might just ask Roche directly via the email address I have given you earlier.

      I hope this helps!

  2. Leslie Sanqui says:

    My husband had been diagnosed with Alzheimer’s, we live in Southern California, and I would like for him to participate. At the moment he is taking Memantine and Donepezil, 5 mg each every day. Please let me know if he can participate, and if this is an open trial. Thank you

  3. Gita Far says:

    my 81 year old mom has been diagnosed with Alzheimer. We live in va.
    do yo know where either one of the two drug are being tested?

    I am interested in any phase 3 drug for mild alzheimer’s disease.

    Can someone please help me with this. Beside Roche who else is running phase 3 on Alzheimer and what state/city is it being conducted.

  4. Roger says:

    Surely this trial is unethical, denying treatment (which is essentially what a placebo group is), for two years. I’m guessing the participants are blinded; thus may think they are receiving a drug which may help their condition (or not) when in fact receiving no active ingredient; thus deteriorating for two year, when they could be receiving current treatment.

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