A free teleconference series offered by UsAgainstAlzheimer's Network covering a wide range of topics with leaders in the Alzheimer's community.
September’s Alzheimer’s Talks focused on the importance of clinical trials, particularly to better understand the motivations and barriers of participation among diverse communities. This call was hosted by Jason Resendez, director of the LatinosAgainstAlzheimer’s network and Dr. Goldie Byrd, Director of the Center for Outreach in Alzheimer’s Aging and Community Health at North Carolina A&T State University.
Dr. Byrd’s work focuses on Alzheimer’s in African American communities, both genetic research and also her center’s priority on community engagement, specifically to involve underrepresented populations in clinical trials and research. They were joined by two very special guests, Daisy Duarte and Valerie Smith, both of whom have volunteered for clinical trials and are also caregivers for loved ones with Alzheimer’s or memory loss. They shared their experiences, and offered insights into the importance of taking part in research and engaging caregivers and patients throughout the research process.
A few key highlights:
We need to focus on under-represented communities in research
Alzheimer’s occurs significantly more often in African Americans and Latinos than in non-Hispanic whites, yet they are underrepresented in clinical trials and research. Community engagement, outreach, and education are crucial to involve underrepresented populations in clinical trials. We need everyone involved so we can make sure a possible treatment works for different groups.
“We’ve been able to advance the science in so many disease areas and we really need to do the same in Alzheimer’s and that takes the engagement of all communities, particularly those who are underrepresented” – Jason Resendez
Better outreach could mean more participation in clinical trials
Studies have often not had diverse and representative samples. Dr. Goldie Byrd’s team has done significant work to better understand what it would take for individuals to participate in a study and the barriers to participation – especially by establishing trust and reducing stigma.
Other suggestions from our guests to increase participation include: involving family members; getting local organizations involved; adding incentives to participate; integrating culture-based activities like food or music; using language that everyone can understand; increasing awareness about Alzheimer’s among younger members of the community; and the importance of the doctor who diagnoses and individual in sharing information about clinical trials.
Our guests decided to participate in a clinical trial to help researchers better understand Alzheimer's and to speed the search for a cure, particularly for their family members.
“I hope that this clinical trial that I’m in is the one that finds a cure” – Daisy Duarte
Ready to volunteer for a study?
Check out Antidote - a tool that can quickly match you with clinical trials in your area.
Your feedback matters
The audience during the call, provided their input on three questions relevant to the discussion:
1) Which type of Alzheimer’s related research would you most be interested in participating in?
2) Would the inclusion of culture-based activities into Alzheimer’s research make them more appealing to you? (ex. salsa dancing, music, traditional foods)?
3) Having learned about or seen the impact of Alzheimer’s on family and friends, what one thing concerns you the most about getting the disease?
Preliminary results are that people are most interested in participating in Alzheimer’s related research around lifestyle modification to prevent Alzheimer’s disease, they would be interested in the inclusion of culture-based activities, and they are most concerned that there are no treatments or cures yet (full results can be found in the transcript).
If you missed the call, please click here to provide your answer to these three questions.
Thank you to Dr. Byrd, Daisy Duarte, and Valerie Smith for sharing their experiences with clinical trials and their ideas for engaging African Americans and Latino populations. This call was in collaboration with the Alzheimer’s and Dementia Disparities Engagement Network (ADDEN), which is a program that is partially funded through a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington Engagement Award.
To learn more, you can listen to an audio playback or read the transcript of the conversation
Dr. Laurie Ryan was our guest for the June Alzheimer’s Talks. Dr. Ryan is Chief of the Dementias of Aging Branch in the Division of Neuroscience at the National Institute on Aging, which is part of the National Institutes of Health (NIH). At the National Institute on Aging, she directs Alzheimer’s disease clinical trials research.
Dr. Ryan discussed efforts and plans to improve the pace and quality of clinical trials and clinical research, with an emphasis on better strategies for recruiting volunteers into trials. The NIA currently has 59 ongoing clinical trials, many in early-stage clinical drug development, as well as a number of trials looking at non-pharmacological or lifestyle interventions.
A few key highlights:
Goals have been set to improve the pace and quality of clinical trials
We have a national goal to prevent and treat Alzheimer’s disease by 2025. The NIA has set recruitment and citizen engagement milestones to improve recruitment into clinical trials/clinical research to help meet the national goals. Key milestones include: Partnering with other federal agencies to create public education campaigns; providing supplemental funding to research studies to help build diverse community partnerships; and using technology to reach more individuals and to assess individuals in their own communities.
The NIH will also be requiring a single institutional review board of record for multi-site trials for any applications after September 2017 to help streamline the process.
We need more volunteers
There is a huge need to recruit large numbers of volunteers, as they typically need to screen ten-times the number of participants to fill each study. Large-scale studies, like the A4 and Generation study, are important but can take years to find enough participants. Special focus is on underrepresented and minority populations, to make sure that potential therapies work for everyone.
How can you participate?
Visit these websites to look for clinical trials that might be a good fit for you:
Thank you to Dr. Ryan for sharing with us all that the NIA is doing to advance recruitment for clinical trials. To learn more, you can listen to an audio playback or read the transcript of the conversation.
Dr. Howard Fillit joined George Vradenburg for this month’s Alzheimer’s Talks to discuss a new report he co-authored, “Single Endpoint for New Drug Approvals for Alzheimer’s Disease”. The report proposes a change in how we define a clinically meaningful drug and therefore the framework for FDA approvals of a possible Alzheimer’s treatment.
It’s time to change the way we measure a drug’s effectiveness.
Standards were set based on decades-old knowledge, and drugs were deemed effective if there were improvements in both cognition and function, co-primary endpoints.
Several advances mean standards need to change.
New developments in biomarkers, such as PET scans, mean that scientists can now determine, with certainty, if someone has Alzheimer’s disease or not. This was not the case 40 years ago. Now, when people take part in clinical trials, we know they have Alzheimer’s disease and the results of the trials are much more relevant.
We have to set realistic expectations.
If we don’t create realistic expectations for the clinical meaningfulness of a drug, we may reduce investment in research. The voice of the patient and caregiver is also crucial to determine what is clinically meaningful.
Other drugs, for conditions such as heart disease, have a single primary endpoint. For Alzheimer’s disease, composite cognition might be the only clinical primary endpoint needed in certain drug trials as there is a fairly linear relationship between loss of cognition and loss of function. A modernization of standards for Alzheimer’s drugs, to make them meaningful and approvable, is necessary.
Prevention is a priority.
Improvements in public health have reduced risk factors. For example, more exercise, better diets, and better management of hypertension and diabetes have been shown to reduce Alzheimer’s risk.
The Alzheimer’s Drug Discovery Foundation has a website called Cognitive Vitality that evaluates the efficacy, safety, and evidence of possible preventions, including supplements and diets.
If you missed the talk—or if you’d like to hear it again—you can listen to an audio playback or read the transcript of the conversation.
Author and journalist Greg O’Brien spoke about his journey into Alzheimer’s disease with Meryl Comer. Greg was diagnosed with early onset Alzheimer’s in 2009, and has been writing, chronicling, and talking about the process ever since. He shared his thoughts, strategies, and experiences in a candid and personal conversation.
Greg’s book, On Pluto, Inside the Mind of Alzheimer’s, has been described as “heartbreaking, defiant, profound” and a new edition will be released this summer. He also has started a podcast series with UsAgainstAlzheimer’s, also called On Pluto.
A few key highlights:
As someone who has Alzheimer’s, Greg shared these tips and strategies to others who have also been diagnosed with, or are progressing with the disease:
- Don’t be afraid to ask questions.
- Be willing to give up control over certain things, but hold on to your essence and strengths.
- Physical exercise can really help reboot the brain.
- Talk about the disease with your family and your community.
- Get involved in clinical trials, telling your story, or advocacy. It will help you realize that you are not alone.
If you are a caregiver with a loved one who has Alzheimer’s, from Greg’s perspective, these are some things that can really make a difference:
- It’s not what you say, but how you say it. Body language and keeping your body calm can help a person who may be frustrated or angry.
- Don’t challenge a question; just go with the disease.
- Say “we” instead of “you” when trying to solve problems.
- Be aware that sundown may be the most difficult time of the day and plan ahead for that.
- Acknowledge your own anger and frustration.
Thank you to Greg O’Brien for talking about his journey with Alzheimer’s. If you missed the talk – or if you’d like to hear it again – you can listen to an audio playback, read the transcript of our conversation, or check out the Storify recap.
Debra Lappin was the guest host for our March Alzheimer’s Talks. She spoke with Dr. Gregory Jicha, Professor of Neurology and the holder of the Robert T. and Nyles Y. McCowan Endowed Chair in Alzheimer’s Disease at the Sanders-Brown Center on Aging at the University of Kentucky Alzheimer’s Disease Center.
Dr. Jicha talked about the impact of genetics on Alzheimer’s risk, how genetic research is affecting the development of medicines, and why individuals with risk genes are important for clinical trials.
A few key highlights:
Risk genes have been identified
Researchers have identified at least eighteen genes that put you at a higher risk for Alzheimer’s. Dr. Jicha stressed that having a risk factor gene does not mean you will definitely come down with Alzheimer’s; also, if you don’t have one of those genes, you could still develop Alzheimer’s so its best to do everything we can for our brain health.
These discoveries help researchers better understand how Alzheimer’s takes hold in the brain, and gives them a “road map” of how medicines might slow, stop, prevent, or perhaps someday even reverse Alzheimer changes in the brain.
Genetics can help personalize medicine
Genes can also help predict a patient’s response to medicines. An individual’s genes can make some medicines more effective or others more risky, so genetic information could help doctors prescribe the best medicines for each individual.
Genetic testing will move the research forward
Though genetic testing is not available commercially for all of the risk factor genes, there are tests available for the genes that may put you at the highest risk for Alzheimer’s. People interested in genetic testing should consult their doctors or genetic counselors.
Clinical trial participation is crucial
Clinical trials could be helped by having genetic information from individuals who carry risk factor genes, especially if they are identified before they develop symptoms of memory impairment.
Getting involved in research is something we can all do to speed the search for a treatment. If you are interested in clinical trials, some places for you to check out include:
Thank you to Dr. Jicha for talking about the links between Alzheimer’s and genetics. If you missed the talk – or if you’d like to hear it again – you can listen to an audio playback or read the transcript of our conversation.