Roche's Clinical Study to Evaluate Neurocognition Measures
Following its 2011 initiation of the study of RG1662, Roche has begun a second new Down syndrome clinical study, “A Non-Drug Study of The Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Individuals with Down Syndrome." The goal of this new study is to evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in individuals with Down syndrome.
“The results of this important new study could enhance our ability to determine the efficacy of new drug therapies,” says Dr. Michael Harpold, DSRTF Chief Scientific Officer and Chair of the Scientific Advisory Board, “as well as further accelerate progress in clinical trials toward improving cognition, memory, and adaptive behaviors in people with Down syndrome. Significantly, this new effort represents the second clinical study focused on Down syndrome initiated by Roche in less than a year.”
The primary objectives of this clinical study include assessing the performance and reliability of specific scales and measures of cognitive function, memory, adaptive behavior, activities of daily living and impact on caregivers. This is a non-drug study; participants will not be required to take any study medication. Study participants will be administered various neurocognitive tests and their caregiver will be asked to complete questionnaires. The study, with duration up to 27 weeks for participants involving approximately three visits, will recruit 90 individuals, ages 12-30 years, with Down syndrome. It is expected that the study completion date will be in fall 2013.
There are currently multiple clinical study sites internationally, including two in the US. The University of Arizona in Tucson, AZ and Duke University in Durham, NC represent the US clinical study sites. Dr. Jamie Edgin, Co-Principal Investigator of the Down Syndrome Research Group and DSRTF-supported researcher, is the study lead at the University of Arizona.
You can learn more about this new clinical study and information concerning participation at clinicaltrials.gov and the Roche Trials Database, or by contacting the Roche Trial Information Support Line at 1 (888) 662-6728 (US only; 6:00 AM - 3:00 PM Pacific Standard Time).
Roche's Clinical Trial of an Investigational Drug, RG1662
In 2011, Roche initiated an early-stage clinical trial, to test an investigational drug in individuals with Down syndrome. The goal is to evaluate its tolerability and obtain an early reading of its effect on the cognitive and behavioral deficits associated with this condition.
“This was very big news for DSRTF last year and represents a very exciting development in the field of Down syndrome cognition research,” says Dr. Michael Harpold, Chief Scientific Officer of DSRTF and Chair of the Scientific Advisory Board. “One of the major goals of DSRTF has been to identify and support the most promising fundamental and translational research through engagement with pharmaceutical companies and clinical trials so that we can develop safe new therapies that will improve cognition in children and adults with Down syndrome. Today, we are seeing years of hard work and dialogue between industry executives, scientists and families come to fruition.”
The first stage of this clinical trial involves individuals with Trisomy 21 who are between the ages of 18-30 and live near one of the eight trial locations around the country. The study lasts approximately 16 weeks and aims to test the tolerability of the investigational drug. During the study, the heart rate, EEG, and laboratory parameters of safety of the participants are monitored very closely, and parents are involved with tracking physical and any emotional/cognitive changes.
Updates on this trial will continue to be provided on clinicaltrials.gov.
Roche’s Clinical Trial on Molecular and Functional Imaging
In August, 2012, Roche initiated a third new Down syndrome clinical trial, “A Molecular and Functional Brain Imaging Study in Individuals with Down Syndrome and Healthy Controls Following Single Dose RG1662”. The goal of this new study is to use MRI and PET imaging scans to evaluate the GABA-A alpha5 receptor expression, occupancy and functional connectivity in the brains of individuals with Down syndrome and healthy controls, ages 18-30 years, following single-dose RG1662. This new study will provide additional clinical information to support RG1662 clinical trials in individuals with Down syndrome.
You can learn more about this study and associated information at clinicaltrials.gov.