A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Center, Double-Blind, Placebo-Controlled, Randomized Blocks Study Investigating the Effect of 4 Dosages (1 mg, 5 mg, 15 mg, 50 mg) of MEM 3454 on P50 Sensory Gating and Mismatch Negativity (MMN) in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: MEM 3454
* Drug: MEM 3454
* Drug: MEM 3454
* Drug: MEM 3454
* Drug: Placebo for MEM 3454


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Male or female subjects between 18and 55 years of age. 2. Fluent in English, even if English is not the primary language. 3. Able to provide informed consent. 4. DSM IV-R primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (SCID CT). 5. Few or no extra-pyramidal symptoms(EPS)at screening,defined as SAS < 6. 6. Negative urine drug screen (UDS). 7. Negative cotinine test. 8. Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. At least one month on the same dose of antipsychotic medication. Exclusion Criteria: Current risk of suicide, or history of suicidal behavior within the last 6 months. Hospitalized for psychiatric symptoms in the past 3 months. Other psychiatric diagnoses. Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the SCID-CT. Currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix). Any medical condition, as judged by the Investigator, which may interfere with the subjects' participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1 mg dose | Drug: MEM 3454<br>* 1 mg dose<br>|
| Experimental: 2<br>5 mg dose | Drug: MEM 3454<br>* 5 mg dose<br>|
| Experimental: 3<br>15 mg dose | Drug: MEM 3454<br>* 15 mg dose<br>|
| Experimental: 4<br>50 mg dose | Drug: MEM 3454<br>* 50 mg dose<br>|
| Placebo Comparator: 5<br>Placebo dose | Drug: Placebo for MEM 3454<br>* Placebo dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454. |  | Pre-dosing and Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Investigate the safety and tolerability of MEM 3454 compared with placebo |  | all time points | 
| • Determine whether MMN correlates with P50. |  | Pre-dose and day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, P50 Sensory Gating, Mismatched Negativity