Summary

Alzheimer’s disease (AD) is an irreversible, progressive neurodegenerative disease, characterized by cognitive impairment, memory loss and functional decline. The pathological features of AD comprise a complex set of histopathological changes within the brain. Symptoms typically begin to first appear in patients in their mid-sixties, and appear in varying stages. The effects of AD, particularly at an advanced stage, are devastating to patients and their caregivers, and are associated with significant associated healthcare costs.

Current treatments focus on sustaining the patient’s cognitive function, managing behavioural symptoms and slowing down the rate of disease progression. There is currently no cure for AD, and only six symptomatic treatment therapies have been approved, of which one (Cognex) is no longer available in the US. The current market leaders are suboptimal in terms of efficacy, and there is therefore a large unmet need within AD to develop safer and more efficacious treatments.

There are numerous differences between many of these products due to their mechanisms of action, and these must be understood fully by companies seeking to position a novel drug in this market. This tabular heatmap framework, designed to provide an easily digestible summary of these clinical characteristics, provides detailed information on all late-stage clinical trial results for products in the AD market and Phase III pipeline. These are split along therapy lines, and are therefore reflective of the treatment algorithm.

All safety and efficacy endpoints reported in these trials are displayed, for both the drug and placebo groups. In addition, key study characteristics such as the size, composition and patient segment of the study population are provided. These results are presented in a visually accessible, color-coded manner in order to maximize ease of use.

The accompanying text provides a detailed analysis of the clinical benchmarks set by the current market landscape, and the anticipated changes to these benchmarks, and to the treatment algorithm, as a result of the late-stage pipeline.

Scope

- What preventative early-stage drugs are generating interest within the AD pipeline?  
- Will the current AD market landscape ensure that the first drug with a disease-modifying mechanism of action will become the market leader?
- What are the clinical characteristics of currently approved therapies for AD, in terms of specific safety and efficacy parameters?
- What are the key unmet needs in this indication, and which clinical safety and efficacy parameters are the most closely linked to them?
- How will current late-stage molecules affect the market for AChEIs, and are they able to yield comparable clinical efficacy results?
- With three amyloid inhibitors present in the late-stage pipeline, do they have sufficient differentiating characteristics from previous clinical failures from this class to have an impact on the market?

Reasons to buy

- Understand the current clinical landscape by considering the treatment options available by drug class.
- Visually compare the currently approved treatments available by drug class, based on the most important efficacy and safety parameters tested in clinical trials.
- Assess the current late-stage pipeline, in terms of the likely positioning of each product and the implications for the clinical landscape at each line of therapy
- Understand the relative strengths and weaknesses of the studies used to gather these data.
- Build up a nuanced understanding of the clinical benchmarks set by these products, and consider how the current late-stage pipeline will affect these benchmarks.
- Assess your own pipeline programs in light of these benchmarks in order to optimally position them and maximize uptake by clinicians.