Hope is hopefully on the way for people diagnosed with schizophrenia who have experienced cognitive deficits caused by their illness.
Allon Therapeutics Inc.'s lead neuroprotective drug candidate davunetide had positive treatment effects in schizophrenia patients with cognitive impairment. The National Institute of Mental Health (NIMH) substantially funded the trial that was managed by Treatment Units for Research on Neurocognition and Schizophrenia (TURNS).
Though statistical significance was not achieved on the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) battery of tests, the trial did result in numerical positive treatment effects in specific tests that measured visual learning and working memory.
It also resulted in a statistically significant positive treatment effect on the UCSD (University of California at San Diego) Performance-based Skills Assessment (UPSA) test. This scale measures the functional capacity of skills for daily living and is recognized by drug regulators as an appropriate co-primary endpoint in patients with cognitive impairment related to schizophrenia.
The davunetide clinical trial was a randomized, double-blind, placebo-controlled, parallel group study precisely to measure the effect of davuentide in patients with schizophrenia-related cognitive impairment. Two doses were compared to placebo: 5 mg once daily and 15 mg twice daily, administered intranasally. The patients were treated for 12 weeks and all were on a stable dose of an anti-psychotic drug. The most commonly reported side effects were headache, restlessness, and sedation.
Davunetide is also being eyed for use in the cognitive impairment associated with Alzheimer's disease and frontotemporal dementia (FTD).
Further clinical trials appear to be warranted. You can find out about investigational studies of new drugs by logging on to the clinical trials web site.
Published On: February 27, 2010