Unmet need

There is no proven treatment or therapy for mild cognitive impairment. As MCI is believed to represent an early state of AD, several treatments proposed for AD, such as cholinesterase inhibitors were tried in the thought that they might be useful. Unfortunately, there are now some indications that the opposite may be true, and that cognitive decline of MCI patients may be accelerated by using AD drugs1.

Unmet need

Adapted from Schneider, L. S. et al. Arch Neurol 2011;68:58-66

At least two major pharmaceutical companies, Eli Lilly and Roche, have recently announced their intention to launch clinical studies focusing on MCI. Eli Lilly’s drug, Solanezumab, was already the subject of a large clinical study for AD, where it failed to meet its primary endpoint, but showed promise on a subset of mile AD patients. In February 2013 Eli Lilly launched a second study to test this hypothesis2. The case for Roche’s drug, Crenezumab, is similar, except its target population is genetically prone to develop early onset AD, and does not necessarily have any symptoms of MCI3.

In recognition of the importance of focusing research efforts towards the early stages of AD (including MCI), the FDA issued in February 2013 a draft Guidance document on developing drugs for the early stages of AD4. In this document, the agency states: “The development of drugs for the treatment of AD has increasingly focused on the range of disease states that occur before the onset of overt dementia because the benefits of a disease­ modifying therapy are presumed to be the greatest in these stages, although no drugs have yet been shown to be effective in such populations.”

1. Schneider, L. S. et al. Arch Neurol 2011;68:58-66

2. http://newsroom.lilly.com/releasedetail.cfm?releaseid=726309

3. http://www.foxnews.com/health/2012/05/16/roche-alzheimer-drug-picked-for-major-test/

4. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf