Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia

Study Overview
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Brief Summary
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To establish the proof of concept that MEM 3454, used as add-on pharmacotherapy, is a safe and effective treatment in patients with cognitive impairment associated with schizophrenia (CIAS).

Official Title
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A Phase 2a, Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MEM 3454 as Adjunctive Treatment in Combination With a Preexisting Antipsychotic in Patients With Cognitive Impairment Associated With Schizophrenia

Conditions
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Cognitive Impairment Associated With Schizophrenia

Intervention / Treatment
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* 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: Diagnosis of schizophrenia (any subtype), assessed using a structured interview. At least one month on the same dose of antipsychotic medication. Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. Able to provide informed consent. Fluent in English. Smokers and non-smokers. Exclusion Criteria: First 3 years of schizophrenia diagnosis. 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. Nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: MEM 3454<br>* Capsule 5 mg once a day<br>|
| Experimental: B<br> | Drug: MEM 3454<br>* Capsule 15 mg once a day<br>|
| Experimental: C<br> | Drug: MEM 3454<br>* Capsule 50 mg once a day<br>|
| Placebo Comparator: D<br> | Drug: Placebo for MEM 3454<br>* Capsule once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the total composite score of the MATRICS cognitive battery at week 8. |  | Change from baseline at wk 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10 |  | Change from baseline - weeks 4 and 10 | 
| Change from baseline on the various cognition tests at Weeks 4, 8 and 10 |  | Change from baseline at Weeks 4, 8 and 10 | 
| Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP |  | Change from baseline at weeks 8 and 10 | 
| Adverse events |  | weeks 2, 4, 6, 8, 10 |