The Complexities of Alzheimer Disease Treatment and Diagnosis in Clinical Trials: Sharon L. Rogers, PhD

WATCH TIME: 6 minutes

"If we want to go after diversity in our patient population for clinical trials, we have to go to them in the way that we approach diagnosis. In terms of diagnosis, it's not something you can solve with a blood test off the shelf; we're talking about another layer of complexity here in the disease that requires a full, thoroughclinical assessment.

The current available treatments for patients with Alzheimer disease (AD) have, to a large extent, failed to produce significant therapeutic benefits, according to recent research.¹ Therefore, researchers recommended that more novel approaches to address this public health issue are needed. Recent data even suggests that intervening early in the first stages of the disease may have a better chance for clinical improvement among patients.1 Additionally, with the increasing incidence of early-onset AD, strategies for making an earlier diagnosis are critical for mitigating cognitive problems in patients at high risk for the disease.²

Having an earlier diagnosis is not only important for patients to get treatment at the first stages of the disease, but it is also helpful for researchers when assessing potential treatments for AD in clinical trials. Patients who get the potential therapies given to them earlier may report positive outcomes, such as cognitive improvement, faster than in a later stage of the disease. Another helpful aid in clinical trials is having a diverse population of patients so that the results are more generalizable for different patient demographics. Achieving a diverse sample of patients in a trial for AD also helps to avoid over–reliance on targeting AD neuropathology.³ There may be several factors that influence the underrepresentation of some minoritized racial and ethnic groups in AD clinical trials, such as differential eligibility, which should be considered during recruitment.⁴

Recently, Sharon L. Rogers, PhD, chief executive officer at AmyriAD Therapeutics and attendee at the 2023 Clinical Trials on Alzheimer Disease (CTAD) conference, held October 24-27, held in Boston, Massachusetts, sat down with NeurologyLive® prior to the meeting to discuss developments in the field of AD. She talked about how disease-modifying therapies in clinical trials for AD show that early intervention is important, and the benefits that can be expected in the early stages of the disease with an earlier intervention. Rogers also spoke about the challenges that arise in reaching mainstream patients with AD, and why it is critical to adapt diagnostic approaches for this patient demographic. She shared her thoughts on how general providers can be better trained to recognize AD earlier through a thorough clinical assessment by ruling out any outside treatable causes.

Click here for more coverage on CTAD 2023.

REFERENCES
1. Stallings NR, O'Neal MA, Hu J, Shen ZJ, Malter JS. Long-term normalization of calcineurin activity in model mice rescues Pin1 and attenuates Alzheimer's phenotypes without blocking peripheral T cell IL-2 response. Alzheimers Res Ther. 2023;15(1):179. Published 2023 Oct 17. doi:10.1186/s13195-023-01323-5
2. Kim DR, Moon E, Shin MJ, Yang YA, Park JH. Effect of Individual Virtual Reality Cognitive Training Programs on Cognitive Function and Depression in Middle-Aged Women: Randomized Controlled Trial. JMIR Ment Health. 2023;10:e48912. Published 2023 Oct 25. doi:10.2196/48912
3. Daly T. Improving Clinical Trials of Antioxidants in Alzheimer's Disease. J Alzheimers Dis. 2023;10.3233/JAD-230308. doi:10.3233/JAD-230308
4. Grill JD, Flournoy C, Dhadda S, et al. Eligibility Rates among Racially and Ethnically Diverse US Participants in Phase 2 and Phase 3 Placebo-Controlled, Double-Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease. Ann Neurol. 2023;10.1002/ana.26819. doi:10.1002/ana.26819