Cognition Pharmaceuticals Announces Positive Memory Results For Phase II Trial Of C105 In Multiple Sclerosis

[Mary]

Cognition Pharmaceuticals Announces Positive Memory Results For Phase II Trial Of C105 In Multiple Sclerosis

Cognition Pharmaceuticals LLC announced positive results from a Phase 2 clinical trial of C105 (l amphetamine sulfate) on 151 Multiple Sclerosis patients with documented cognitive dysfunction.

In the six-week placebo-controlled study, Cognition Pharmaceuticals reported, the active group obtained significantly higher scores on secondary outcome measures of memory and learning, including the Brief Visuospatial Memory Test - Revised, Total Recall (p = 0.041) and Delayed Recall (p < 0.01), and the California Verbal Learning Test, Long Delay Free Recall (p = .012). Safety data were unremarkable with a limited side-effect profile.

The company said that C105 demonstrated efficacy in improving memory function in patients with cognitive impairment secondary to MS. At the 30mg peak dose, the active group exhibited statistically significant improvement in performance on measures of both verbal and nonverbal delayed recall as well as improved memory retention.

Merit Designation

A report of the study findings has been awarded a Merit designation by the International Neuropsychological Society (www.the-ins.org) in anticipation of its 2009 conference in Atlanta where the study will be presented. The International Neuropsychological Society is a multi-disciplinary non-profit organization dedicated to enhancing communication among the scientific disciplines which contribute to the understanding of brain-behavior relationships. The Merit designation means that the abstract was identified as being among the most highly rated of all research submitted and reviewed for the meeting.

Study Results

While the results did not reach statistical significance for either of the two primary outcome measures focusing on processing speed and executive function (the Symbol Digit Modalities Test and the Subject's Global Assessment), the significant memory findings coupled with an encouraging safety profile clearly define the drug's effects and differentiate it from d-amphetamine in clinically meaningful ways, Cognition Pharmaceuticals said. Continued analyses of study data in several domains is in process.

"We are extremely encouraged by very strong findings in the areas of verbal and visual memory and learning from our trial. These memory results are consistent with and fit well with our understanding of the mechanism of action of C105 as documented in a range of preclinical and clinical studies," according to Cognition Pharmaceuticals President and Chief Scientific Officer David Erlanger, Ph.D.

The potential for C105 to help human memory was first identified by a team of researchers led by Mark Bear, Ph.D., currently Director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology. "In animals, we discovered that C105 can modulate memory consolidation -- a biochemical process by which temporary or labile changes in synaptic function are made enduring. We believe that C105 augments the function of modulatory systems in the brain that normally control memory strength. It is very exciting to see that this insight may be of therapeutic significance in humans with memory disorders."

Analyses of the full dataset from the trial are ongoing, with Drs. Ralph Benedict and Frederick Munschauer of the Jacobs Neurological Institute in Buffalo, New York serving as Co-Principal Investigators. A series of discussions with leading medical experts and publication of more detailed results over the coming months are under way.

More on
http://www.medicalnewstoday.com/articles/133434.php