November 5, 2024
2024 has been an exciting year for clinical trials for people with Lewy body dementia (LBD). Over the past year, you have heard a lot from the Lewy Body Dementia Association (LBDA) about two Phase 2 clinical trials of experimental drugs in people with Dementia with Lewy bodies (DLB) – SHIMMER, a trial of the investigational drug CT1812, and RewinD-LB, a trial of the investigational drug neflamapimod. Thanks to the willingness of the LBD community to participate in research, both of these trials met their participation enrollment goals and are therefore no longer accepting new participants. We hope to be able to share some preliminary results from these studies with the LBD community in the coming year, once the trials have been completed.
In the meantime, there are many other studies that are currently recruiting new participants. You can learn more about these studies, including study locations and study team contact information, by visiting the LBDA clinical studies page. And if you would like to be kept up-to-date by email when new studies are launched, consider joining the Lewy Trial Tracker.
The studies we list all have locations within the United States or welcome virtual participation. But did you know that LBD clinical trials are occurring all around the world? For example, there are currently at least three clinical trials underway for DLB in Europe.
The COBALT trial
The COmBining memantine And cholinesterase inhibitors in Lewy body dementia Treatment trial (COBALT) is testing a combination of two classes of medication to see if it improves overall health and functioning in people with LBD, including both DLB and PDD. The combination being studied includes memantine and a cholinesterase inhibitor – either donepezil, rivastigmine or galantamine. The COBALT trial is occurring in the United Kingdom under the auspices of the National Health Service.
Proof-of-concept rTMS trial
At the University Hospital in Strasbourg, France, researchers are testing the feasibility and potential benefit of a new kind of treatment for people with DLB. Rather than using an experimental drug, this study examines the effect of changing brain activity using powerful magnetic fields that can reach across the skin and bone to reach the brain from outside the body. This technique being studied is called “repetitive transcranial magnetic stimulation,” or rTMS. In particular, the researchers are studying whether rTMS may help reduce cognitive fluctuations in DLB.
The ANeED trial
In Norway, researchers at memory clinics are studying the safety and potential beneficial effect of ambroxol, a drug already used for certain cough conditions, in people with DLB. Called the Ambroxol in New and Early DLB (ANeED) trial, this study is particularly focused on cognition, functioning, and neuropsychiatric symptoms, such as depression and hallucinations. Regardless of whether a participant is randomly assigned to the placebo treatment or the active treatment for the first year and a half of the study, all participants will be offered the active treatment for the final year of the trial.
The AXON trial – Australia
Building on the theme of using existing drugs in new ways, researchers on the other side of the world, in Australia, are launching a trial of a combination therapy that includes both ambroxol and the antibiotic drug doxycycline. The study, entitled A Phase II pilot study to determine protocol feasibility, and potential efficacy for disease modification of combined Doxycycline and Ambroxol in Dementia with Lewy Bodies (shortened to “AXON”) began accepting participants in 2023, and is testing the drug combination in 32 people over six months of treatment. The researchers hope that the study will result in information that can be used to plan larger trials in the future.
What does this mean for me and my family?
Even if you do not live near one of these study locations, you will still benefit from them. Trials happening anywhere help people with LBD everywhere. Regardless of the results of these specific studies, they will add to the body of knowledge that scientists draw upon in their continued search for effective therapies.