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Nicotinic alpha-7 receptor agonist
1 for Schizophrenia (P50 Trial)
Phase 2
Waitlist Available
Led By Ann Olincy, MD, MPH
Research Sponsored by Memory Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and day 1
Awards & highlights
P50 Trial Summary
The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio. Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.
P50 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ all time points
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all time points
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454.
Secondary outcome measures
• Determine whether MMN correlates with P50.
• Investigate the safety and tolerability of MEM 3454 compared with placebo
P50 Trial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: 4Experimental Treatment1 Intervention
50 mg dose
Group II: 3Experimental Treatment1 Intervention
15 mg dose
Group III: 2Experimental Treatment1 Intervention
5 mg dose
Group IV: 1Experimental Treatment1 Intervention
1 mg dose
Group V: 5Placebo Group1 Intervention
Placebo dose
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Who is running the clinical trial?
Hoffmann-La RocheIndustry Sponsor
2,431 Previous Clinical Trials
1,090,056 Total Patients Enrolled
18 Trials studying Schizophrenia
8,020 Patients Enrolled for Schizophrenia
Memory PharmaceuticalsLead Sponsor
4 Previous Clinical Trials
483 Total Patients Enrolled
1 Trials studying Schizophrenia
160 Patients Enrolled for Schizophrenia
Ann Olincy, MD, MPHPrincipal InvestigatorUniversity of Colorado, Denver
Frequently Asked Questions
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