Emerging importance of computerized cognitive testing -- new therapies for dementia

(Press-News.org) Boston, MA – Computerized cognitive testing is increasingly playing a key role in therapy development for dementia and Alzheimer's disease. This week at the Alzheimer's Association International Conference, Keith Wesnes Ph.D., Practice Leader of Bracket and founder of the CDR System™, discussed new data for novel therapies at two poster presentations at the Alzheimer's Association International Conference. Poster Title: Cognitive evidence in Alzheimer's disease patients that compromised hippocampal neurogenesis is related both to APOE4 status and CSF Abeta42 This presentation provides the first behavioural data in Alzheimer's patients which associates genetic and biomarker activity to dysfunction in a major brain area involved both in memory and the production of new nerve cells (neurogenesis), This exciting finding obtained in collaboration with a group including Kaj Blennow, University of Gothenburg, found that patients with two APOE ϵ4 alleles (which confer a 10 to 30 fold increased risk of developing Alzheimer's disease) showed a selective decline in a computerised cognitive test measure associated with activity in the hippocampal dentate gyrus. Furthermore, in all patients studied, this test measure was more closely associated with the levels of the Aβ42 biomarker for the disease than a number of other memory measures associated with different hippocampal regions. As interest in Alzheimer's research is shifting to begin treating the disease at its earliest stages, these findings identify a potential genetic and biomarker strategy for selecting individuals for early treatment with therapies which may promote hippocampal neurogenesis. Poster Title: Memantine improves attention and verbal episodic memory in Parkinson's disease dementia and dementia with Lewy bodies: a double-blind placebo-controlled multicentre trial A second presentation provides the first data that performance on objective tests of attention and memory can be improved by memantine in two other major forms of dementia - Parkinson's disease dementia and dementia with Lewy Bodies. The improvements detected were highly statistically reliable and of clinically relevant effect sizes; indicating that memantine can produce cognitive benefits in patients with these dementias which match those seen previously with anticholinesterases. Both studies utilised the CDR System™, an automated cognitive test system, making a strong case for benefits for the increased sensitivity and specificity that such procedures bring to dementia research, when compared with the traditional tests which have been historically employed. Another recent Alzheimer's trial conducted by Orion Corporation demonstrated proof of concept of a new drug with a novel mode of action. The phase II clinical trial tested ORM-12741 -- the first drug to target a specific subtype of adrenergic receptors (alpha-2c) in the brain, which are believed to be involved in modulation of brain functions under stressful conditions. The trial of 100 patients showed significant positive effects on episodic memory in patients with moderate Alzheimer's disease. Efficacy was assessed using the CDR System™. ### For more information on the trial, please go to: http://www.orion.fi/congress-publications

Much of the slow progress in developing new drugs to treat Alzheimer's disease (AD) has been due to the advanced stage of deterioration which exists when the disease is first identified, plus the reluctance to use computerised tests to assess the benefits to cognitive function, despite these having been in use in dementia research for over 30 years and guidelines dating back to 1997 recommending their inclusion. In 1986, Professor Wesnes founded Cognitive Drug Research Ltd. to offer the CDR System™ as a service in international clinical trials. The CDR System™ has become the most widely used automated method in worldwide drug development and has been used successfully in over 25 therapeutic trials in various dementias including AD and the prodrome for AD, Mild cognitive Impairment. About Bracket Bracket was created in 2011 through the merger of the Specialty Clinical Services and Clinical Technologies Group business units within United BioSource Corporation, which was acquired by pharmacy benefit manager Medco Health Solutions, which was then acquired by Express Scripts. Bracket partners with sponsors and contract research organizations to achieve greater certainty and accurate outcomes in their clinical trials by providing a combination of scientific, technological and operational support, from Phase II to post approval. Service groups are divided into two technology and scientific resources – eClinical and Scientific Services. eClinical services are technology-driven solutions, applicable across many therapeutic areas. Bracket's Scientific Services target indications which are dependent on subjective endpoints to evaluate safety, efficacy and value and include Endpoint Reliability, Trial Enhancement Services and Computerized Cognitive Testing. In 2012, Bracket joined 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. The members of the ePRO Consortium collaborate in a non-competitive, neutral environment to develop guidelines and advance the quality of electronic data collection methods for PROs. With more than 13 years of experience, Bracket's team of experts has worked on more than 1,100 successful trials across 47 therapeutic areas with a particular emphasis on the central nervous system. Bracket leads the speciality services field in the U.S., U.K., Continental Europe and Japan. http://www.bracketglobal.com