Schizophrenia affects approximately 3 million people in the US, and it is one of the leading causes of disability. Currently available drugs are only partially effective, particularly for the cognitive impairments that contribute to functional loss. A new investigational drug, BMD-101, has been shown to have neuroprotective, neurotrophic, cholinergic, and dopaminergic effects in laboratory animals and appeared to benefit cognitive symptoms in limited clinical trials conducted in China. This research will test whether BMD-101 when used together with existing drugs may more effectively treat the cognitive and functional impairments of schizophrenia than is now possible. The merit and feasibility of this approach will be established over two years by conducting a randomized, double-blind, placebo-controlled, 6-month add-on trial comparing two doses of BMD-101 to placebo in 72 patients with schizophrenia who have not responded optimally to current therapy. The primary outcome for this pilot study will be cognitive improvements as assessed by the NIMH- and FDA-developed MATRICS battery. A co-primary functional outcome measure will be evaluated to meet FDA requirements for the indication of treating cognitive dysfunction in schizophrenia. Additionally, safety will be assessed by adverse event report, physical exam, vital signs, weight, EKG, and laboratory tests of hepatic, renal, hematologic, and metabolic function. Data on effect sizes and safety will guide design of definitive efficacy studies. The milestones for year one will be randomization of 48 patients in the trial, retention for 13 weeks of 75% of subjects with completion of the week 13 follow-up MATRICS assessment, and retention for 26 weeks of 66% with completion of the week 26 follow- up MATRICS assessment. The milestones for year two will be randomization of 72 patients in the trial, retention for 13 weeks of 75% of subjects with completion of the week 13 follow-up MATRICS assessment, and retention for 26 weeks of 66% with completion of the week 26 follow- up MATRICS assessment. Schizophrenia affects approximately 3 million people in the US, and it is one of the leading causes of disability.
Currently available schizophrenia treatments are only partially effective, particularly for the cognitive impairments that underlie functional deficits associated with the illness. This research focuses on developing a new medication with cognition-enhancing and neuroprotective properties that when used together with existing medications may more effectively treat the cognitive and functional impairments of schizophrenia.
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