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April 1, 2022

Aphasia: where are the clinical trials?

Aphasia trigger and the inherent challenge of standardising behavioural treatments are key considerations in clinical trials.

By Reynald Castañeda

Actor Bruce Willis overnight became the face of aphasia upon the announcement that he is stepping down from acting on the back of his diagnosis. This led to Clinical Trials Arena having a look at the development pipeline for aphasia in both drug and medical devices.

And as it turns out, there’s not many ongoing trials. While there’s been several reasonably sized studies over the past few years, aphasia is generally an underresearched area, says professor of cognitive neurology Alexander Leff at the University College in London. Aphasia is a condition that affects one’s language skills.

GlobalData’s Medical Intelligence Center Clinical Trials database tracks five medical devices at the clinical stage of research and one that is still in early development. Meanwhile, there are 13 ongoing drug Phase I-III trials in aphasia, four of which are specific to Broca’s aphasia, as per GlobalData’s Clinical Trials database. Broca’s aphasia is a type of nonfluent aphasia.

Aphasia patient heterogeneity a clinical trial challenge

Perhaps the main challenge in aphasia clinical trials is patient heterogeneity, says professor of neurology Stefano Cappa at the University School for Advanced Studies IUSS in Pavia, Italy. There are two triggers to aphasia: stroke and neurodegenerative disorders like dementia, with the latter group referred as having primary progressive aphasia (PPA). The next layer of complexity is that it is inherently hard to standardise behavioural treatment, Cappa adds.

There have been several clinical trials investigating neurostimulation procedures such as transcranial magnetic or electric stimulation for PPA, Cappa says. These are designed to introduce electrical changes in the brain. But the challenge here is their transient effect – it is ideal to either have a long-lasting impact or slow the language disorder in PPA, he adds.

Mobile apps a key tool in aphasia?

Particularly in stroke patients, the key intervention is speech and language therapy, Leff says. However, in the real world, patients are not getting enough. While the idea is to get as much as 30-50 hours of therapy, under the NHS patients only get four hours of therapy during inpatient care, and then between six to eight hours in a community setting, Leff notes.

To address this need, there are mobile phone apps that are available to get patients practicing as much as 100 hours, Leff says. But the challenge with these apps is that they are not as holistic as an in-person therapy, he adds. Aphasia is a language problem, and language has four tenets: speaking, writing, listening, and reading. Apps may only focus on one of these four domains, while therapy can address all four simultaneously, he adds.

There have been effort to develop pharmaceutical interventions, but the issue here is that aphasia is due to a knock-on effect by a different neurological issue, Cappa explains. This means that if there would be pharmaceutical drugs, they would not be designed to target aphasia directly but the neurological disease responsible, he explains. “Which also explains why there are not many trials labelled as for aphasia,” he adds. Pharmaceutical drugs that aim to bolster the brain’s learning ability is unlikely to work by themselves;  there would still be a requirement for active learning, Leff adds.

This article was first published on Clinical Trials Arena.

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