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Share your lived experience with DLB with the FDA.

Have you been diagnosed with Lewy body dementia?

There are two types. Some people are diagnosed with a cognitive disorder called dementia with Lewy bodies (DLB), sometimes informally called Lewy body dementia (LBD). Other people are diagnosed with Parkinson’s disease and later develop dementia, which is called Parkinson’s disease dementia.

Watch the EL-PFDD Meeting on DLB

The Lewy Body Dementia Association, in collaboration with the Alzheimer’s Association, hosted the first-ever Externally-Led Patient-Focused Drug Development (EL-PFDD) Meeting on DLB on October 15, 2024.

Watch the meeting on-demand, and share with your family, care partners and health care providers.

You still have time to share your experience with the FDA!

Safe and effective drugs are urgently needed to treat dementia with Lewy bodies (DLB). Don’t miss this opportunity to share your lived experience with DLB with the FDA. If you attended the live meeting or are watching it for the first time, your voice is an essential part of the drug development process, regardless of how DLB came into your life or where you are along the journey.

Whether you are living with DLB, a family member or care partner of someone with the disease, a health care provider or clinical researcher, the FDA wants to hear from you. Below you will find a few topics to guide you. Use the form to submit your comments by November 15, 2024!
(Please only submit a comment on one topic at a time.)

Which DLB symptoms impact your life the most?

How does DLB affect you on the best and worst days? (Please describe each.)

How have your symptoms changed over time? How has this affected your ability to cope?

As you look to the future, what worries and frustrates you most about your condition?

What are you currently doing to manage your DLB symptoms?

How well do these treatments address the symptoms that impact you the most? And are there any significant downsides to the treatments?

Short of a complete cure, what specific things would you look for in an ideal treatment for DLB?

Voice of the Patient Report

As an outcome of the EL-PFDD meeting, LBDA will publish the Voice of the Patient Report. This landmark report will include all the perspectives and shared experiences from the DLB community captured before, during and after the meeting, as well as a detailed summary and analysis of the data and insights. This report will be accessible via lbda.org and shared with the FDA, clinical researchers, drug developers and other key stakeholders as an important tool to guide and inform the development of better treatment options for those living with DLB.

FAQs

  • What is Patient-Focused Drug Development?

    Patient-Focused Drug Development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs and priorities are captured and meaningfully incorporated into drug development and evaluation. Click here to learn more about Patient-Focused Drug Development.

  • What is an Externally-Led Patient-Focused Drug Development meeting?

    Usually referred to by its acronym, EL-PFDD, is a special meeting type defined by the US Food and Drug Administration (FDA) to ensure that drug developers at pharmaceutical companies and universities, in addition to FDA staff, hear directly from people living with a disease and those who care for them. Click here to learn more about EL-PFDD meetings.

  • What are the topics?

    An EL-PFDD usually focuses on two primary topics having to do with drug development:

    • The patient (and caregiver) lived experience, with a focus on how the disease impacts your day-to-day life.
    • Patient (and caregiver) thoughts about current treatment options and their hopes/fears related to the treatment horizon.
  • Who will host the meeting?

    The EL-PFDD will be planned and hosted by LBDA, in consultation with the patient and caregiver community.

  • Who will speak during the meeting?

    An EL-PFDD is solely focused on the patient's voice. With the exception of two doctors, who will provide general overviews of the condition and the treatment landscape, all speakers will be DLB patients and caregivers.

    In general, patients should speak for themselves. Caregivers may also provide input, but it should be focused on the impact of the disease on the patient, rather than on the caregiver. We realize that the caregiver voice is incredibly important, but drug developers and the FDA need to understand the impact on the patient, specifically, because that is who drugs are developed for.

    In general, patients should speak for themselves. Caregivers may also provide input, but it should be focused on the impact of the disease on the patient, rather than on the caregiver. We realize that the caregiver voice is incredibly important, but drug developers and the FDA need to understand the impact on the patient, specifically, because that is who drugs are developed for.
  • Will the focus be on LBD, DLB, or PDD?

    This particular EL-PFDD will focus on DLB. However, anyone from the public is strongly encouraged to attend.

  • Will I have an opportunity to speak or otherwise provide input?

    Yes! The entire point of the meeting is for your voice to be heard, documented, and shared with drug developers and the FDA. During the virtual meeting, there will be a toll-free number to call and share your experiences.

    In addition, written comments will be welcome during the meeting and for 30 days after the meeting via the EL-PFDD webpage on lbda.org.

  • What happens after the meeting?

    The meeting will result in several durable outcomes:

    • The recording of the meeting will be hosted lbda.org and our YouTube channel, LBDAtv, and accessible to anyone, free of charge.
    • A written report of the meeting will be generated. This "Voice of the Patient" report will also be hosted by LBDA on the web.
    • The report and the link to the recording will be shared by LBDA with drug development researchers and the FDA.

    Click here for additional information and FAQs, provided by the U.S. Food & Drug Administration.

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