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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00604760

Enrollment

160

Registered

2008-01-30

Start date

2007-12-31

Completion date

Unknown

Last updated

2008-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment Associated With Schizophrenia

Brief summary

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).

Interventions

DRUGPlacebo for MEM 3454

Capsule once a day

DRUGMEM 3454

Capsule 5 mg once a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026