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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00725855

Acronym

P50

Enrollment

Registered

2008-07-31

Start date

2008-08-31

Completion date

2009-04-30

Last updated

2008-07-31

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

Conditions

Schizophrenia

Keywords

Schizophrenia, P50 Sensory Gating, Mismatched Negativity

Brief 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.

Interventions

DRUGMEM 3454

1 mg dose

DRUGPlacebo for MEM 3454

Placebo dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Contacts

Primary ContactAnn Olincy, MD,

ann.olincy@uchsc.edu303-315-5046

Outcome results

None listed

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