Pharmacists at the Forefront: Enhancing Care for Patients With Alzheimer Disease Receiving Disease-Modifying Treatment

According to the Alzheimer’s Association, approximately 7 million individuals in the US live with Alzheimer disease (AD), and that number is expected to rise to 15 million by 2050. This not only underscores the already significant burden but also highlights the need for novel therapies and comprehensive approaches. As clinical understanding of AD deepens and novel drugs are introduced to the disease’s treatment paradigm, pharmacists play a crucial role in educating, monitoring, and supporting patients with AD.¹

Older man discussing treatment with pharmacist | Image Credit: © fizkes - stock.adobe.com

AD is an incurable, progressive neurodegenerative disease characterized by memory loss, cognitive decline, and eventually, functional impairment. The disease's evolution is seen as successive, with mild cognitive impairment (MCI) and stages of mild, moderate, and severe dementia. Historically, treatment of AD was focused on managing cognitive and behavioral symptoms, which was done through the use of cetylcholinesterase inhibitors and memantine. However, these are not likely to slow disease progression or alter the disease’s trajectory.²

Research has uncovered the molecular mechanisms underlying AD, revealing that its pathophysiology is driven by the accumulation of amyloid-beta (Aβ) and tau deposition in the brain. These abnormal protein deposits, which mark the progression of AD, begin forming 10 to 20 years before symptoms appear. Thus, research has been focused on the development of Aβ-targeting agents as potential disease-modifying treatments (DMT).²

As of February 2025, there are 3 FDA-approved DMTs for clinical use as Aβ-targeting therapies (ATTs). These are aducanumab (Aduhelm; Biogen), lecanemab (Leqembi; Biogen, Eisai Co, Ltd), and donanemab (Kisunla; Eli Lilly and Co), all of which target different variants of Aβ.²

Lecanemab, a recombinant human immunoglobulin gamma 1 (IgG1) monoclonal antibody, is the latest addition to FDA-approved Aβ-targeting agents. It was granted accelerated approval based on data from the Study 201 (NCT01767311) and Study 301 (NCT03887455) trials, where the treatment yielded sustained benefits through 36 months. The authors reported that upon stopping therapy with lecanemab, there was a reaccumulation of amyloid biomarkers, highlighting its significant clinical benefit and a critical need for sustained maintenance dosing of the therapy. Lecanemab is administered intravenously every 4 weeks and indicated for patients with early AD who exhibit MCI or mild dementia stage of disease.^3-6

“For maintenance treatment, once every 4 weeks dosing regimen may be easier than once every 2 weeks dosing for patients and care partners to continue treatment for early AD,” the manufacturer said in a press release. “Ongoing treatment can slow disease progression and prolong the benefit of therapy, with the goal of helping patients maintain who they are for longer.”³

Pharmacists are often at the forefront of guiding patients through their treatment and consulting frequently with caretakers during routine encounters. They could play a role in evaluating patients receiving lecanemab to determine if a maintenance dose would be beneficial, as well as ensure patients understand and adhere to the treatment schedule, monitor for potential side effects such as amyloid-related imaging abnormalities (ARIA), and coordinate with other healthcare providers to optimize patient outcomes.²

Adherence is a significant challenge in AD treatment, as symptoms—such as memory loss or reduced cognitive function—can affect a patient’s ability to remember to take their medications, making it more difficult to follow complex dosing schedules. Caregivers are often responsible for medication management of patients with AD; however, obstacles can occur that interrupt treatment. The less frequent dosage schedule for maintenance lecanemab may facilitate pharmacist administration and increase the likelihood that patients will receive their doses on time, adhere to the prescribed treatment plan, and maintain therapeutic benefits while reducing the burden on caregivers.^2,7

Older woman holding pill packages | Image Credit: © leroy - stock.adobe.com

Donanemab is a humanized IgG1 monoclonal antibody that was approved for patients with early AD and is intended to lessen Aß plaques by targeting insoluble N-truncated pyroglutamate Aß. It has a terminal elimination half-life of roughly 12.1 days and reaches a steady condition following a single dosage. The donanemab-azbt is recommended to be given at a dose of 700 mg intravenously every 4 weeks for the first 3 doses, then 1400 mg intravenously every 4 weeks, with each dose administered over approximately 30 minutes. Similar to lecanemab, donanemab offers patients and pharmacists an efficacious treatment with a manageable dosing schedule to overcome the obstacles of treatment adherence in patients with AD.⁸

“I'm excited about the future of pharmacists and cognitive care, and that also extends to patients that are on [donepezil] and talking to them [patients] about what's actually been done, have they been considered for the anti-amyloid therapy, and understanding that medication recognition as an early sign that someone should be considered for additional treatment is super important,” said John Showalter, MD, MSIS, dementia prevention and cognitive care internal medicine physician, and chief product and strategy officer at Linus Health.⁹

As the landscape of AD treatment continues to evolve with the introduction of disease-modifying therapies, pharmacists play a vital role in ensuring patients receive the full benefits of these advancements. From educating patients and caregivers to monitoring adherence and collaborating with healthcare professionals, pharmacists are positioned to help overcome the challenges associated with cognitive decline and complex treatment regimens. With therapies like lecanemab and donanemab offering structured dosing schedules, pharmacists can further support sustained treatment, ultimately helping patients maintain their cognitive function and quality of life for as long as possible.

REFERENCES

1. Alzheimer's disease facts and figures. Alzheimer’s Association. Accessed February 17, 2025. https://www.alz.org/alzheimers-dementia/facts-figures

2. Pharmacists can help patients navigate current treatment landscape of Alzheimer disease. Pharmacy Times. January 10, 2025. Accessed February 17, 2025. https://www.pharmacytimes.com/view/pharmacists-can-help-patients-navigate-current-treatment-landscape-of-alzheimer-disease

3. FDA approves lecanemab-irmb maintenance dosing for early Alzheimer disease treatment. Pharmacy Times. January 27, 2025. Accessed February 17, 2025. https://www.pharmacytimes.com/view/fda-approves-lecanemab-irmb-maintenance-dosing-for-early-alzheimer-disease-treatment

4. A study to evaluate safety, tolerability, and efficacy of lecanemab in subjects with early Alzheimer’s disease. Updated January 22, 2025. Accessed February 17, 2025. https://clinicaltrials.gov/study/NCT01767311

5. A study to confirm safety and efficacy of lecanemab in participants with early Alzheimer’s disease (Clarity AD). Updated July 9, 2024. Accessed February 17, 2025. https://clinicaltrials.gov/study/NCT03887455

6. Leqembi™ (lecanemab-irmb) - CAM 910. Medical Policies. January 2025. Accessed February 17, 2025. https://www.southcarolinablues.com/web/public/brands/medicalpolicy/external-policies/leqembi-lecanemab-irmb/#:~:text=Leqembi%20is%20an%20amyloid%20beta,insoluble%20forms%20of%20amyloid%20beta

7. Arlt S, Lindner R, Rösler A, von Renteln-Kruse W. Adherence to medication in patients with dementia: predictors and strategies for improvement. Drugs Aging. 2008. doi:10.2165/0002512-200825120-00005

8. Kisunla From Eli Lilly. Pharmacy Times. November 21, 2024. Accessed February 17, 2025. https://www.pharmacytimes.com/view/kisunla-from-eli-lilly

9. Mild cognitive impairment is extremely undiagnosed, expert says. Pharmacy Times. September 20, 2024. Accessed February 17, 2025. https://www.pharmacytimes.com/view/mild-cognitive-impairment-is-extremely-undiagnosed-expert-says