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AAIC 2023 | A review of current clinical trials in dementia with Lewy bodies

Carla Abdelnour, PhD, Stanford University, Palo Alto, CA, talks on the findings of a recent systematic review of clinical trials in dementia with Lewy bodies (DLB), aiming to identify current patterns in drug therapy trials and guide the introduction of learnings from trials in other dementias. The systematic review incorporated 40 trials, investigating 25 agents, and revealed several challenges in expediting drug development for DLB. These included a lack of Phase I trials, a predominance of repurposed agents, a focus on mild-moderate dementia stages, and the use of outcome measures not validated for use in DLB populations. Dr Abdelnour noted several positive trends, including a large number of different mechanisms of action being studied for potential disease modification and an effort to include more patients in the prodromal phases of disease. To advance DLB therapeutics, disease-specific outcome measures and improved global representation in trials are essential. This interview took place at the Alzheimer’s Association International Conference® (AAIC) 2023 in Amsterdam, Netherlands.

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Transcript (edited for clarity)

We did a systematic review on clinical trials for dementia with Lewy bodies because we wanted to update the information that has been recently published and also we wanted to incorporate some elements that have been used in Alzheimer’s and Parkinson’s disease to our study, and we ended up analyzing three international registries. We found 412 records and we incorporated 40 clinical trials that investigated 25 agents...

We did a systematic review on clinical trials for dementia with Lewy bodies because we wanted to update the information that has been recently published and also we wanted to incorporate some elements that have been used in Alzheimer’s and Parkinson’s disease to our study, and we ended up analyzing three international registries. We found 412 records and we incorporated 40 clinical trials that investigated 25 agents. These agents are being studied in dementia with Lewy bodies but we found some challenges that we think we have to address if we want to speed up the process of drug development in dementia with Lewy bodies.

Some of these challenges is that there are very few clinical trials in Phase I. Also, most of the clinical trials investigate repurposed agents. This is not inherently a bad thing. It just means that a lot of the agents have been developed for Alzheimer’s and Parkinson’s and then evaluated in dementia with Lewy bodies. So we actually need more therapies especially targeted for dementia with Lewy bodies. Also, most of the clinical trials include patients in the mild to moderate dementia stage, although now recently more trials are including patients in the prodromal stage. We found that the outcome measures usually have not been validated for dementia with Lewy bodies. The biomarkers are being used as secondary endpoints, but very few clinical trials use biomarkers as an inclusion criteria. Lastly, there is a lack of diversity because the majority of the trials have been conducted in the US or Europe. So we think that these challenges pose some opportunities for us to improve our ability to conduct clinical trials in dementia with Lewy bodies. For that, we think that we have to be able to develop disease specific outcome measures, detect patients at early stages of the disease. In addition, we have to improve our ability to have a global representation and include diverse population in clinical trials. But the bottom line is that we need more clinical trials in dementia with Lewy bodies because we have very few therapeutic options for our patients.

Well, there are now clinical trials for disease modifying treatments for dementia with Lewy bodies. There are several elements in our review. We found different mechanisms of actions that are being studied currently and we think that those are novel therapeutic targets. I don’t want to mention just one of them because I don’t want to favor any of them, but I think it’s exciting to see that there is a broad range of mechanisms of actions that are being studied and if you want to know more, we recently published a review on that topic.

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Disclosures

Carla Abdelnour has received the Sue Berghoff LBD Research Fellowship, and honoraria as speaker from F. Hoffmann-La Roche Ltd, Zambon, Nutricia, Schwabe Farma Ibérica S.A.U. She is member of the Board of Directors of the Lewy Body Dementia Association.