With the advent of novel disease-modifying therapies (DMTs), the future of Alzheimer’s disease (AD) diagnosis and management has been a key theme at the AD/PD 2023 International Conference on AD and Parkinson’s disease (PD), says GlobalData, a leading data and analytics company.

Pippa Salter, Senior Neurology Analyst at GlobalData, comments: “Following the FDA approvals of Biogen’s Aduhelm (aducanumab), and Eisai and Biogen’s Leqembi (lecanemab), the first DMTs for AD, earlier diagnosis can now have a significant impact on disease progression and quality of life (QoL) for patients.

“Currently, significant barriers exist for diagnosing AD. These include a lack of awareness of brain health and cognitive impairment in the general population and among primary care physicians, and delays in referral to specialists. This will delay the initiation of DMTs, which will reduce the positive impact they can have.”

Blood-based biomarkers (BBBMs) have the potential to help streamline the diagnostic process, thereby improving management of AD. Once highly validated BBBM tests become widely available, an initial blood test in a primary care setting could highlight patients who are at high risk of progressing to AD and who could be fast-tracked to receive a DMT.

Salter continues: “Ultimately, the goal for AD is the prevention of disease. As this can only be achieved by therapeutic intervention prior to the development of symptoms, biomarkers will also play a crucial role in prevention strategies. The development of non-invasive, relatively cheap, and easy-to-use BBBMs for this could enable widespread use for everyone during routine clinical checkups.”

With Lilly’s donanemab expected to be the third DMT to enter the AD market behind Aduhelm and Leqembi, competition between these drugs is set to increase. As such, the developers are all looking at how to best position their product on the market.

At AD/PD 2023, Lilly presented new Phase II data highlighting the potential for the beneficial effects of donanemab to continue beyond the cessation of treatment. Lilly is the first company to investigate the effect of halting treatment with an anti-Aβ mAb, which could help give donanemab a competitive advantage. While these results are important for Lilly, it will also be important for them to be replicated and further evaluated in larger ongoing Phase III clinical trials.

Salter concludes: “In AD, a disease with a particularly high burden for both patients and caregivers, measures of QoL and patient-reported outcomes due to a therapy are of particularly high value. QoL data presented by Eisai and Biogen at AD/PD 2023 showed the meaningful benefit of lecanemab treatment as felt by both patients and caregivers, thereby adding value to the drug, and providing context beyond clinically significant clinical trial endpoints.”