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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

We wish to thank all patients who have participated in the development of aducanumab. We remain dedicated to working with urgency with the purpose of meaningfully changing the course of Alzheimer’s disease. We understand that you may have many questions about aducanumab. We will try to answer them below.

  1. What did Biogen announce in October 2019?
    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. The Phase 3 EMERGE study met its primary endpoint, as per the pre-specified statistical analysis plan, showing a statistically significant reduction in clinical decline compared to placebo. Biogen also showed results from a subset of patients in the ENGAGE study, who were randomized to the 10 mg/kg high dose of aducanumab, that support the findings from EMERGE.
    2. Patients from the high dose group in EMERGE experienced 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.
  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 wish to thank all patients who have participated in the development of aducanumab. The protocol of the re-dosing study that aims at offering access to aducanumab to all eligible patients who were actively enrolled in the aducanumab studies in March 2019 has been successfully submitted to the FDA. We are now working with U.S. trial sites to initiate this open-label clinical trial, which does not include a placebo-controlled arm. In the U.S., we expect the first patients to be re-dosed starting in March 2020. We are also actively working in Europe and Japan to re-open sites there, and are engaging with other markets around the world, which requires seeking approval by regional regulatory authorities and institutional review boards.
  1. What is the “re-dosing study” about?
    1. Our objective with this trial is to offer aducanumab to eligible patients who were actively enrolled in aducanumab trials when they were discontinued in March 2019. The trial’s primary objective is to evaluate the long-term safety and tolerability of aducanumab. The primary outcome measures are: number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs); number of participants with AEs to treatment discontinuation or trial withdrawal; number of patients with ARIA-E or ARIA-H; and number of patients with anti-aducanumab antibodies in serum.
  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. The trial will offer access to aducanumab to eligible patients actively enrolled in the aducanumab studies in March 2019, including the aducanumab Phase 3 studies (ENGAGE & EMERGE), the long-term extension study for the Phase 1b PRIME study and the EVOLVE safety study.
    2. We have aimed to make the eligibility criteria as inclusive as possible, in line with study requirements.
    3. As with any clinical study research protocol, there are inclusion and exclusion criteria that must be met to help ensure participants are safe and able to fulfill all the protocol requirements.
    4. For example, there are no minimum or maximum age limits for inclusion in the trial. There will not be the need to be above any threshold on cognitive tests. The study will be an open-label, single-arm longitudinal study, with all participants receiving aducanumab – including prior placebo arm participants.
    5. More details are now available at www.clinicaltrials.gov.
    1. Are there any sites currently active? If so, have any patients been enrolled and begun treatment?
      1. The timing for trial site activation will vary among the different sites and countries, since a new study requires approval by regional regulatory authorities and institutional review boards. As more sites open, physicians or study coordinators will contact previously actively enrolled patients to share more details and advise on appropriate steps.
      2. The trial protocol has been successfully submitted to the FDA. We are now working with U.S. trial sites to initiate this open-label clinical trial, which does not include a placebo-controlled arm. In the U.S., we expect the first patients to be re-dosed starting in March 2020. We are also actively working in Europe and Japan to re-open sites there, and are engaging with other markets around the world, which requires seeking approval by regional regulatory authorities and institutional review boards.
      1. How soon might I resume aducanumab?
        1. The timing for trial initiation will vary among the different sites and countries, and as this progresses, physicians or study coordinators will contact patients to share more details and advise on appropriate steps.
        2. In the U.S., we expect the first patients to be re-dosed starting in March 2020.
        1. What is the dosing and duration of treatment?
          1. All participants will be titrated to 10 mg/kg aducanumab intravenous (IV) infusions every 4 weeks. The duration of the redosing study will be for 100 weeks.
        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. Physicians or study coordinators will contact patients to share more details and advise on appropriate steps. Eligibility for the re-dosing study will be evaluated on a case-by-case basis.
        1. Where can I find out more information about how to get access to the drug again?
          1. Physicians or study coordinators will contact patients to share more details and advise on appropriate steps.
        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. Your physician or study coordinator will contact you to share more details and advise on appropriate steps for enrollment. Patients should consult their doctor to discuss eligibility at that time. The current eligibility criteria for this study don’t include a limit on disease stage, as long as the participant is deemed able to comply with protocol-related tests and procedures by the site investigators.
        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. The patient’s physician or study coordinators will contact patients to share more details and advise on appropriate steps for enrollment.
          1. What did Biogen present at the 12th Clinical Trials on Alzheimer’s Disease (CTAD)?
            1. On December 5, 2019, Biogen presented additional details from EMERGE and ENGAGE, two global Phase 3 studies for aducanumab at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Congress in San Diego, CA. During this presentation, Biogen shared the topline data on the primary and secondary clinical endpoints based on the pre-specified statistical analysis plan, as well as data from disease biomarker sub-studies, including amyloid PET, tau PET and tau CSF biomarkers. Furthermore, we presented patient demographic characteristics and safety results from each study. LEARN MORE