Following a period of relative dormancy, research and development in the Alzheimer’s disease space is booming. And mounting attention, both in the development of disease modifying therapies (DMTs) and tests for the diagnosis of the disease, remain as important as ever.
Over seven million people in the US are living with Alzheimer’s disease, with this number projected to rise to , as per the Alzheimer’s association.
According to GlobalData analysis, biopharmaceutical companies developing Alzheimer’s disease innovator drugs have witnessed a flurry of acquisitions over the past few years, surging in total deal value by more than 780% from Recent deals that have contributed to this rise include AbbVie’s 2024 acquisition of Aliada Therapeutics for $1.4bn, including its anti-pyroglutamate amyloid beta (3pE-Aß) antibody ALIA-1758, which is currently in Phase I trials for Alzheimer’s disease. There are currently 782 pipeline drugs in Alzheimer’s disease in active stages of development, as per GlobalData’s Pipeline Drugs database.
Eisai and Biogen’s Leqembi (lecanemab) and Eli Lilly’s Kisunla (donanemab), which were approved by the US Food and Drug Administration (FDA) in January 2023 and July 2024, respectively, represent the most significant DMTs available for Alzheimer’s disease.
According to GlobalData analysis, Leqembi and Kisunla are forecast to generate global sales of approximately However, since their respective approvals, both drugs have experienced market-related issues.
ed by the UK’s National Institute for Health and Care Excellence (NICE) for use in the UK’s National Health Service (NHS) on the grounds of an unfavourable risk-benefit profile and poor cost-effectiveness. While Leqembi has been approved by the European Medicines Agency (EMA), Kisunla has not, with the agency asserting that the drug’s benefits do not outweigh the risks associated with amyloid-related imaging abnormalities (ARIA), which can cause brain swelling and bleeding.
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By GlobalDataLeqembi targets soluble amyloid-beta (Aβ) protofibrils with the aim to inhibit their formation, while Kisunla targets a form of aggregated Aβ called pyroglutamate-modified amyloid plaques. While both anti-Aβ monoclonal antibodies have different mechanisms of action, they were each developed and gained approval for use in patients in the early stages of Alzheimer’s disease, with the drugs’ efficacy most pronounced when treatment begins at this early stage.
With this in mind, tests for earlier Alzheimer’s disease diagnosis, along with advisory from clinicians to seek a diagnosis for the disease earlier, have been gaining steam for some time, under the rationale that the earlier Alzheimer’s disease patients can be diagnosed, the more likely they are to benefit from DMTs such as Leqembi and Kisunla.
³Ô¹ÏºÚÁÏÍø Network sat down with Cristiano Tunesi, international business lead at Roche Neurology Diagnostics to learn how Roche is advancing efforts to detect Alzheimer’s disease earlier.
Ross Law (RL): What work is Roche currently undertaking to improve the early detection of Alzheimer’s disease?
Cristiano Tunesi (CT): At Roche, we recognise that identifying patients before the symptoms of Alzheimer’s disease appear is of critical importance, because earlier diagnosis means that earlier interventional action can be taken.
To this end, we see significant potential in integrating digital tools with fluid biomarkers to enhance early detection. In the upcoming months, we are planning to launch several Alzheimer’s disease biomarkers. We are also exploring digital solutions in order to develop an end-to-end solution in early detection – with the overall aim to democratise the early detection of amyloid pathology to improve access to disease modifying therapies (DMTs) for Alzheimer’s disease.
RL: Why have you decided to focus on early detection?
CT: At this time, we are primarily focused on early detection because it is now understood that the earlier you can detect Alzheimer’s disease patients, the higher the likelihood of finding a solution or treatment that could be effective. But currently there are several key barriers towards the early detection of Alzheimer’s disease. First, it often takes around two years for patients to get an Alzheimer’s disease diagnosis; we need to shorten that timeline, because it’s too late. A lot of the research on the drugs for Alzheimer’s disease indicate that the earlier we can get those patients diagnosed – potentially even before disease symptoms appear – the better the results when it comes to treating the disease are likely to be. Overall, this is why we have decided to focus on early diagnosis and try to develop a blood-based solution that will enable physicians, and in turn patients, to obtain an earlier diagnosis.
RL: Tell me more about Roche’s biomarkers for Alzheimer’s disease.
CT: In 2018, we marketed our Elecsys cerebrospinal fluid (CSF) immunoassays for beta-amyloid (1-42) and phosphorylated tau (181P). This autumn, we are launching our pTau181 blood test for measuring phosphorylated Tau (pTau) 181 protein in the blood. This will be the first blood-based biomarker from Roche that will tackle Alzheimer’s disease. Designed for patients with early or mild Alzheimer’s disease symptoms, the test is able to identify the absence of amyloid pathology in diverse patient populations.
We are also developing plasma pTau217 that aims to identify individuals with amyloid pathology. In this case, it will be a positive result, indicating a high likelihood of amyloid pathologies. A negative result will indicate a high likelihood that amyloid is not present, and there will be also an ‘intermediate zone’, indicating that further diagnostic testing is required.
What is important is that these tests always have to be used alongside other clinical information for the diagnostic pathway of Alzheimer’s disease. But one element we want to underline is that we want to enhance access, so we are generating real world data across primary and secondary care settings in the US, Europe and other countries with a focus on the disease’s early stages.
RL: How is Roche combining these assays with brain imaging findings to support less invasive diagnostic modalities?
CT: When we look at the Alzheimer’s disease journey, we also consider the current unmet needs, some of which are immediately clear. There is a difficulty in obtaining an accurate diagnosis early enough for patients using only cognitive tests, so blood-based biomarkers can definitely add value.
Along with the aforementioned lengthy diagnosis timelines, there can be further barriers when it comes to imaging, with PET scans often both costly and not widely available. Meanwhile, blood-based biomarkers represent the exact opposite. With blood-based biomarkers, our aim is to provide a diagnostic that is minimally-invasive due to its accuracy – thereby mitigating the need for more invasive approaches to confirming an Alzheimer’s disease diagnosis – and also cost-effective and healthcare agnostic, given that a blood draw can be taken anywhere so will democratise the access to this kind of diagnostic solution.
However, depending on the patient being assessed, a blood-based solution may need to be linked together with a clinical assessment. But in certain situations, and looking ahead, it may in future be enough to have such confirmatory amyloid tests without further clinical assessment. What is important is that these results should not be taken as a standalone; for now, it is often worth looking at patients on an individual basis and defining if an additional imaging or CSF test is appropriate.
RL: Where do you foresee Alzheimer’s research and development heading in the coming years?
CT: We envision a future in which Alzheimer’s disease can be prevented. Currently, there are significant resources focused on identifying individuals that are at risk while they remain symptom-free and healthy. So, this will enable an early intervention through lifestyle modification or targeted immunotherapy to potentially delay or even prevent the disease’s onset.
The other trend exists in precision healthcare. In this area there is a move towards developing blood-based biomarkers that could serve multiple critical functions. These could involve targeted screening of high-risk populations, obtaining an accurate diagnosis to guide treatment decisions, or undertaking prognoses to predict disease progression.
