The PLACQUE (progression limitation in Alzheimer’s: clioquinol’s efficacy) trial will be conducted over 52 weeks and will enroll 435 patients in the UK, Australia and the Republic of South Africa. The purpose of the study is to assess the efficacy of two dose levels of PBT-1 (clioquinol) when added to the current therapy of patients with moderate Alzheimer’s disease.
The trial will be randomized, double blind and placebo-controlled. The primary endpoint of the study will be to demonstrate a reduction in the progression of Alzheimer’s as measured by the Alzheimer’s disease assessment scale-cognition (ADAS-cog).
Receiving clinical trials authorization (CTA) approval is a significant milestone for Prana, as the future of PBT-1 was uncertain this time last year due to patent litigation with PN Gerolymatos, and other concerns. With the initiation of the PLACQUE trial, Prana now stands poised to become a late stage development company.
“We are extremely hopeful that PBT-1 will be the first drug to target what is believed to be the root cause of Alzheimer’s disease – the accumulation of amyloid plaques in the neocortex of the brain,” said Jon Alsenas, CEO of Prana. “Clioquinol appears to be one of the lead candidates to have a significant impact on both clinical symptoms and disease progression.”
Prana expects to have two promising Alzheimer’s drugs in the clinic in 2005, with the PBT-1 phase II/III PLACQUE study initiating in the second quarter and the PBT-2 phase I clinical trial also commencing in early 2005.
The company also continues to focus upon developing a pipeline of drugs for the treatment of other disorders where inappropriate protein aggregation plays a key role, such as in Parkinson’s disease.