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Aducanumab is an investigational drug and is not approved for use in the U.S. or any other country.

Aducanumab Clinical Trial Participants

Thank you for your participation in the development of aducanumab. We understand that you may have many questions about what this announcement may mean for you. We will try to answer them below.

  1. What did Biogen announce?
    1. Biogen plans to file for market approval for aducanumab in the U.S. based on a new analysis of a larger dataset and discussions with the U.S. Food and Drug Administration (FDA).
      1. We believe that results from a subset of patients in the ENGAGE study who received sufficient exposure to high dose aducanumab support the findings in the EMERGE study.
    2. This new analysis showed that compared to placebo, greater exposure to high dose aducanumab resulted in significant benefits on measures of cognition and function such as memory, orientation and language, as well as activities of daily living such as conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home.
    3. If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes compared to placebo.
  1. I was previously enrolled in an aducanumab study. What does this mean for me? Am I eligible to participate in the re-dosing study?
    1. First of all, we want to thank you for your participation in this research program. We intend to start a re-dosing study as soon as possible and we are seeking guidance from regulatory authorities, principal investigators and institutional review boards in order to do so.
    2. We aim to offer access to aducanumab to eligible patients actively enrolled in the aducanumab studies in March 2019, including the aducanumab Phase 3 studies, the long-term extension study for the Phase 1b PRIME study and the EVOLVE safety study. We will provide more details on the eligibility criteria as they become available.
  1. What is the “re-dosing study” about?
    1. The re-dosing study is an aducanumab study designed to evaluate its long-term effects. The study aims to enroll eligible patients who were actively enrolled in the aducanumab studies in March 2019.
    2. The final details of the study activities are still being worked out and we are working with the goal of setting up the re-dosing study as quickly as possible. The aim is to make the eligibility criteria as inclusive as possible in line with the requirements for the study. There will be no placebo arm so eligible patients will receive aducanumab.
  1. I read in the news release that “eligible patients” will be offered to enroll in a re-dosing study and receive treatment. Who will be eligible?
    1. This study will be offered to eligible patients who were actively enrolled in any of the aducanumab studies in March 2019 (Phase 3 studies, Phase 1b PRIME, and EVOLVE safety study). The study will be an open-label, single-arm longitudinal study, with all participants receiving aducanumab.
    2. The aim is to make the eligibility criteria as inclusive as possible, for example, there will not be the need to be above any threshold on cognitive tests.  However, as with any clinical study research protocol, there are inclusion and exclusion criteria that must be met to ensure participants are safe and able to fulfill all the protocol requirements.
    3. We understand the urgency to know more and are committed to provide further details on the study as soon as we can. Once details are available they will be posted to clinicaltrials.gov
  1. How soon might I resume aducanumab?
    1. We are working with the goal of setting up the re-dosing study as quickly as possible. The process to initiate a new study varies from country to country as it needs to be approved by regional regulatory authorities and institutional review boards.
    2. Once more details are finalized, your physician or study coordinator will be able to share more details and advise on appropriate steps for you.
  1. I was in an aducanumab trial but when the trial was stopped, I joined another clinical trial. Can I still come back and get aducanumab?
    1. Ongoing participation (or within the last 12 months) in any study with an investigational drug may impact your eligibility to participate in the aducanumab re-dosing study.
    2. Once more details are finalized, your physician or study coordinator will be able to share more details and advise on appropriate steps for you.
  1. Where can I find out more information about how to get access to the drug again?
    1. We are working to start the re-dosing study as soon as possible. Once more details are finalized, your physician or study coordinator will be able to share more details.
    2. Aducanumab will only be available in the re-dosing study to eligible patients who were actively enrolled in an aducanumab study in March 2019.
    3. We are working to submit a drug application to the FDA, which we plan to do in early 2020, and we will continue dialogue with regulatory authorities in international markets, including Europe and Japan, for other potential submissions.
    4. A drug application is the formal step a company takes to propose to get the required approval to market a drug to patients.
  1. My dementia is getting worse over the past year, and I am wondering if I still qualify for the study? Should I still anticipate a benefit of aducanumab treatment?
    1. Individual patient cases may vary. We recommend you seek advice from your physician.
  1. I was in an aducanumab study but was not actively enrolled at the time of study discontinuation in March 2019. Why am I not eligible in the re-dosing study?
    1. Eligibility for the re-dosing study will be evaluated on a case-by-case basis.
    2. Once more details of the re-dosing study are finalized, your physician or study coordinator will be able to share more details and advise on appropriate steps for you.
  1. When will you present the data?
    1. We plan to present further detail at the Clinical Trials on Alzheimer’s Disease (CTAD) meeting in San Diego in December 2019.
  1. When will I hear more?
    1. We are now moving forward on the ground of positive clinical results, in consultation with the FDA, with a sense of urgency as we feel a deep responsibility to bring this potential treatment to patients as soon as possible.
    2. We are finalizing the details of a re-dosing study with the aim to offer access to aducanumab to eligible patients actively enrolled in the aducanumab clinical studies in March 2019. We know timing is critical and we will work with regulatory authorities and principal investigators with a sense of urgency.