Biotie Therapies Selects Bracket's CDR System™ for Phase 2 PD Trial: Cognitive function is primary endpoint

Biotie Therapies Selects Bracket's CDR System™ for Phase 2 PD Trial: Cognitive function is primary endpoint

July 15, 2014

(Copenhagen, Denmark) – Bracket is pleased to announce that Biotie Therapies, a specialized drug development company focusing on products for neurodegenerative and psychiatric disorders, has selected the CDR System for use as the primary endpoint for their phase 2a trial of SYN120, an orally administered, dual 5HT6/5HT2a antagonist, in Parkinson's disease patients with dementia. Biotie is collaborating with the Michael J. Fox Foundation and the Parkinson Study Group to conduct the study which will commence this year in approximately 10 US Sites.

Bracket's proprietary CDR System is a computerized cognitive testing method which has been used successfully in numerous therapeutic trials in various dementias including Parkinson's disease dementia and Alzheimer's disease. The System assesses the major domains of cognitive function that are vulnerable to normal and pathological aging. Over the last 30 years, it has been used in almost 1,300 clinical trials across 50 indications. The CDR System works in all research settings with any patient population and is utilised throughout the drug development process.

"Researchers worldwide have used the CDR System to help identify the full range of cognitive deficits in the various dementias, and also to serve as an instrument to definitively measure the benefits of treatment," said Professor Keith Wesnes. "I'm delighted that Biotie has selected the CDR System for this very important trial."

About Bracket
Bracket partners with sponsors and CROs to achieve greater certainty and accurate outcomes in clinical trials by providing scientific, technological and operational support, from Phase I to post approval. Bracket's eClinical services are technology-driven solutions, applicable across many therapeutic areas. Bracket's Scientific Services target indications that are dependent on subjective endpoints to evaluate safety, efficacy and value, and include Endpoint Reliability, Trial Enhancement Services and Computerized Cognitive Testing.

Bracket is a member of the Electronic Patient-Reported Outcome (ePRO) Consortium, a program run by the Critical Path Institute (C-Path). The collaboration works to improve the quality of patient reported outcomes, a crucial element in the drug development process.

Bracket leads the specialty services field in the U.S., U.K., Continental Europe and Japan. www.bracketglobal.com

 

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.