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The current state of amyloid targeting treatments in Alzheimer’s Disease was reviewed in another Citeline blog, but here, we will zoom out to look at the overall landscape and also provide a preview of our upcoming presentation which will be delivered at the SCOPE conference taking place February 23-25 in Miami, FL.

 

 

Alzheimer’s is the most common form of dementia, and accounts for 60% to 80% of dementia cases. [1] The disease is a significant public health problem, and the prevalence of the disease continues to grow. Datamonitor Healthcare® estimates 9.5 million prevalent cases of Alzheimer’s across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, UK) in 2014, and forecasts it will increase to 14.8 million by 2034. [2]

 

 

Based on these projections, research in this area is imperative and, according to Trialtrove®, there are over 90 active Phase I/II-III industry sponsored trials involving early stage Alzheimer’s patients. Trial activity is greatest in the 7 major markets (US, UK, Germany, France, Spain, Italy, Japan), while disease prevalence is highest in China and the US (Figure 1).

 

Figure 1. Active Trials for Early Stage Alzheimer’s by Location and Disease Prevalence

 

Figure-11-700x427

 

Source: Trialtrove®, Datamonitor Healthcare®, Alzheimer Europe Organization, Alzheimer Society Canada, Alzheimer’s Australia, December 2015

 

The US has the second highest disease prevalence rate with 375 in 100,000 and the greatest number of active Alzheimer’s trials (55). While China has the highest disease prevalence rate, 64 in 100,000, there are only 2 active trials disclosed for this country. In looking at the top trial locations for early stage Alzheimer’s and their disease prevalence data, how does this information compare with the number of top investigators located in these countries?

 

 

Sitetrove® includes 1,862 investigators with experience conducting Alzheimer’s studies globally, and 1,263 investigators with direct experience in early Alzheimer’s Disease. The Sitetrove® Investigator Prioritization functionality was utilized to identify investigators with significant experience in early Alzheimer’s and who currently have the greatest capacity to conduct a study. This proprietary algorithm incorporates aspects of overall trial experience, availability, recentness of activity, and disease specific search parameters in order to rank investigators into three tiers, with Tier 1 and Tier 2 investigators having the highest potential to perform as a group compared to Tier 3.

 

 

Figure 2. Sitetrove® Investigators with Direct Experience in Alzheimer’s Disease Trials

 

figure-2smaller 

Source: Sitetrove®, December 2015

As depicted in Figure 2, there are 853 Tier 1 and Tier 2 investigators with direct experience in early Alzheimer’s, no FDA regulatory actions, and no identified, competing early Alzheimer’s phases I/II-III industry sponsored trials. The greatest number of Tier 1 and Tier 2 investigators are found in the United States (332), followed by France (135), then China, Canada, and Germany, each with 41. Low trial activity, high disease prevalence, and top investigator experience are found in Brazil and China, so it may be worthwhile to consider these countries for future Alzheimer’s trials (Figure 3).

 

Figure 3. Active Trials for Early Stage Alzheimer’s by Location, Disease Prevalence, and Prioritized Tier 1 and Tier 2 Investigators

figure-3


Source: Trialtrove®, Sitetrove®, Datamonitor Healthcare®, Alzheimer Europe Organization [3], Alzheimer Society Canada [4], Alzheimer’s Australia [5], December 2015

 

Alzheimer’s Disease prevalence continues to grow, and there is an increased demand for early stage Alzheimer’s research. Data-driven approaches to country, site, and investigator selection, and using the highest quality data available, ensures the greatest potential for success. Do you have access to the best data to drive your critical clinical trial decisions?

 

 

For more details, be sure to see Citeline’s sponsored presentation, “Integrating multiple data sources to optimize site selection in Alzheimer’s Disease” on Wednesday, February 24th at SCOPE in Miami, FL.

[1] Alzheimer’s Association

[2] Datamonitor Healthcare

[3] Alzheimer Europe Organization

[4] Alzheimer Society Canada

[5] Alzheimer’s Australia

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