Alzheimer's disease and dementia

Background and objectives

Our client, a major player in the CNS area, wanted to obtain an accurate, current assessment of Alzheimer's disease product development and clinical trials.

We were presented with six companies and 19 products to assess, by focusing on:

• Safety profiles of products in trials
• Clinical development plans
• Clinical end points
• The plans and intentions
• The plan for interim data analysis
• Whether the Phase 3 trial design would be a randomised withdrawal or standard parallel arms

Approach

We set up two advisory boards, one in the US and one in the EU, with KOLs (principal investigators and lead investigators) and each group was moderated by a PhD level expert in Alzheimer's disease. We set up a two-day meeting in each continent, where the clients could observe and table further questions.
The participants were given the following points to discuss:

• Exploration of future treatment/management scenarios
• Clinical trial strategy and design - end points, development plans and data
• Issues regarding registration procedures
• Exploration of target product profiles (TPPs)
• Reaction to major clinical trial results
• Product development strategy

Results delivered

The proceedings were content analysed in great detail, and the results presented in the form of a written report as well as a personal presentation and discussion.