Eli Lilly trial reveals Alzheimer's drug that significantly slows cognitive decline

A recent phase three study conducted by Eli Lilly examined the safety and efficacy of the study drug donanemab in participants with early Alzheimer's disease (AD).

Study: LillyStudy: Lilly's Donanemab Significantly Slowed Cognitive and Functional Decline in Phase 3 Study of Early Alzheimer's Disease. Image Credit: Ground icture/Shutterstock.com

Background

The pharmaceutical company Eli Lilly announced in a press release on May 3, 2023, that a clinical trial of the experimental Alzheimer's drug, donanemab, showed it could significantly slow the progress of cognitive decline, allowing patients increased independence.

The drugmaker's announcement revealed that the drug succeeded in halting early AD progression in nearly half of the participants, slowing cognitive decline rates by 35% compared to control participants.

Donanemab is an antibody that targets protein aggregates, known as amyloid beta proteins, which are the causative agents of brain plaques. Despite the direct causes of Alzheimer's being unknown, brain plaques have been thought to slow brain function and thus advance cognitive decline.

If the therapy were approved by the Food and Drug Administration (FDA), it would become the third Alzheimer’s drug to enter the market in the past three years. Safety concerns remain despite the promising trial results, with at least two participants experiencing fatal brain swelling.

About the study

The study, known as TRAILBLAZER-ALZ 2, is a phase three, placebo-controlled, double-blind study that aimed to explore the safety, tolerability, and efficacy of N3Pg antibody in early AD patients with brain tau pathology.

The study enrolled 1,736 participants that were selected following cognitive assessments, amyloid plaque imaging, and tau staging.

All participants had early AD, including individuals with mild cognitive impairment (MCI) and mild dementia. The primary analysis population comprised 1,182 individuals with an intermediate tau level and clinical AD symptoms. The study also enrolled 552 individuals with high tau levels at baseline, representing those at a later disease progression.

All participants were aged between 60 to 85 and were not undergoing immunoglobin G therapy. The study measured the efficacy of donanemab by evaluating how likely participants were to progress across Alzheimer's categories, such as MCI to mild dementia or from mild dementia to moderate.

More information on the study will be revealed in the peer-reviewed journal paper that has yet to be published.

Results

In the primary analysis population, the primary endpoint, the integrated Alzheimer's Disease Rating Scale (iADRS), showed a 35% slowing of decline (p<0.0001). The secondary endpoint (Clinical Dementia Rating Sum of Boxes, CDR-SB) showed a 36% slowing of decline (p<0.0001) over 18 months.

Additionally, in this primary population, 47% of participants that took donanemab showed no CDR-SB decline, a key measure of cognitive disease. 52% of participants had completed treatment within 12 months, and 72% within 18 months. Finally, participants on donanemab were at a 39% lower risk of progressing to a worse disease stage than placebo.

The secondary analysis population also showed promising results across both endpoints, with iARDS and CDR-SB showing a 22% and 29% decline, respectively.

In addition, TRAILBLAZER-ALZ-2 also reduced brain amyloid plaque levels from six months following treatment, with many patients reaching levels characterized as negative for pathology. Of these, 34% in the primary study population reached amyloid clearance at six months and 71% at 12 months.

What's next?

In sum, donanemab treatment slowed clinical decline by 35% compared to the placebo. Furthermore, it resulted in a 40% lowered decline in the ability to perform daily activities, bettering individual quality of life.

All primary and secondary study endpoints and aims were met, showing a clinically significant benefit. Lilly will proceed rapidly with global regulatory submissions and make an FDA submission. The FDA, Lilly, and other regulators will work together to achieve traditional approvals.

Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said...

These Phase 3 data confirm the benefit observed in our TRAILBLAZER-ALZ study and show that donanemab if approved, may represent a significant step forward for people with early symptomatic Alzheimer's disease, and allow them to continue to participate in activities that are meaningful to them,"

Furthermore, Anne White claims...

We believe our data meets the 'high level of evidence' the Centers for Medicare & Medicaid Services (CMS) has described as the trigger for reconsideration of its National Coverage Determination. People with early Alzheimer's disease need and deserve full coverage and access for approved therapies."

Source:
Lily Ramsey

Written by

Lily Ramsey

Lily holds a distinguished academic background, having earned a first-class degree in Microbiology from the University of Nottingham in 2021. Her pursuit of knowledge continued as she completed her LLM in Medical Law and Ethics at the University of Edinburgh. During her master's studies, Lily dedicated her research to the field of public health ethics, with a specific passion for health equity and justice, with a specialized focus on the ethical aspects of antibiotic resistance.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Ramsey, Lily. (2023, May 04). Eli Lilly trial reveals Alzheimer's drug that significantly slows cognitive decline. News-Medical. Retrieved on June 17, 2024 from https://www.news-medical.net/news/20230504/Eli-Lilly-trial-reveals-Alzheimers-drug-that-significantly-slows-cognitive-decline.aspx.

  • MLA

    Ramsey, Lily. "Eli Lilly trial reveals Alzheimer's drug that significantly slows cognitive decline". News-Medical. 17 June 2024. <https://www.news-medical.net/news/20230504/Eli-Lilly-trial-reveals-Alzheimers-drug-that-significantly-slows-cognitive-decline.aspx>.

  • Chicago

    Ramsey, Lily. "Eli Lilly trial reveals Alzheimer's drug that significantly slows cognitive decline". News-Medical. https://www.news-medical.net/news/20230504/Eli-Lilly-trial-reveals-Alzheimers-drug-that-significantly-slows-cognitive-decline.aspx. (accessed June 17, 2024).

  • Harvard

    Ramsey, Lily. 2023. Eli Lilly trial reveals Alzheimer's drug that significantly slows cognitive decline. News-Medical, viewed 17 June 2024, https://www.news-medical.net/news/20230504/Eli-Lilly-trial-reveals-Alzheimers-drug-that-significantly-slows-cognitive-decline.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Vigorous exercise linked to lower dementia risk in hypertensive individuals