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

(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.

Bracket to Present at AAIC 2014

The Alzheimer’s Association International Conference is right around the corner. Taking place in Copenhagen, Denmark on July 11-17, the conference will bring together thousands of researchers to reveal the latest research in dementia.

Bracket’s Dr. David Miller, Therapeutic Area Leader for Dementia and Geriatric Psychiatry, collaborated on four scientific posters with his industry and academic colleagues. Below is a list of their posters. Be sure to check back on our website after the conference for links to the posters.

Regional Variation in Alzheimer’s Disease Progression in a Clinical Trial Setting
David Henley, Sherie Dowsett, Yun-Fei Chen, Hong Liu-Seifert, Joshua Grill, Rachelle Doody, Paul Aisen, Rema Raman, David Miller, Ann Marie Hake, Jeffrey Cummings

To facilitate enrollment and meet local registration requirements, sponsors have increasingly implemented multi-national Alzheimer’s disease (AD) studies. Regional variability is expected but understanding the degree can be helpful in planning AD study implementation.

Comparing Recruitment Among Geographic Regions in Multinational Alzheimer’s Disease Clinical Trials
Joshua D. Grill, Rema Raman, Karin Ernstrom, Sherie Dowsett, Yun-Fei Chen, Hong Liu-Seifert, Ann Marie Hake, Paul Aisen, Rachelle Doody, David Miller, David Henley, Jeffrey Cummings

Alzheimer’s disease (AD) clinical trials frequently struggle to enroll. To address this consistent challenge, most AD clinical trials now recruit multi nationally. Demographic and clinical measures were compared for participants and their study partners from four similarly-designed, randomized, double-blind, placebo-controlled trials. For all outcomes, the hypothesis that global regions do not differ from each other was tested.

Revising the Administration of the ADAS-Cog
Kimberly Schafer, Paul Aisen, Richard Mohs, Amy Veroff, Donald Connor, David Salmon, David Miller, Mary Sano, Peter Boehm, Christopher Weber, Nicholas Greco, Barbra LaPlante, Sarah Walter, Lon S. Schneider, and the ADCS ADAS Review Group

The ADAS-Cog (Rosen et al., 1984) is widely used as the primary or co-primary outcome measure in clinical trials. The administration manual for the ADAS-Cog was first prepared in 1994 by Richard Mohs, revised in 1998, and has been broadly distributed by the Alzheimer’s Disease Cooperative Study Group (ADCS). The manual needed updating and revision to reduce inconsistent interpretations of administration instructions and scoring. The goal was to revise the US version which could then serve as a primary reference for use in other regions and languages.

Drug Development for Agitation and Aggression in Alzheimer’s Disease (AD): Study Design and Outcome Measures in Phase 2 Study of Scyllo-inositol (ELND005 Study AG201)
Susan Abushakra, J Patrick Kesslak, Matthias Kurth, Frank Fan, Menghis Bairu, David Miller, and Constantine Lyketsos

Agitation and Aggression are among the most disruptive neuropsychiatric symptoms (NPS) in Alzheimer’s disease (AD) and occur in up to 50% of AD dementia patients. ELND005 (Scyllo-inositol, a myo-inositol isomer) is being evaluated as a potential treatment for Agitation and Aggression in AD (clintrials NCT01735630). This poster describes the operational diagnostic criteria & novel outcome measures utilized in this trial, and baseline characteristics of the population.

The poster presentations will take place:
Wednesday, July 16
11:45am – 2:15pm
Bella Center A/S, Center Boulevard 5, DK-2300 Copenhagen S

Dr. Miller will also be participating in the Neuropsychiatric Symptoms Professional Interest Area of the PIA day program on Saturday morning, July 11, at the Bella Sky Hotel and Co-Chairing the NPS PIA Business meeting later that same morning.

View the full conference agenda here.