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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725855
Recruitment Status : Unknown
Verified July 2008 by Memory Pharmaceuticals.
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2008
Last Update Posted : July 31, 2008
Hoffmann-La Roche
Information provided by:
Memory Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: MEM 3454 Drug: Placebo for MEM 3454 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
1 mg dose
Drug: MEM 3454
1 mg dose
Experimental: 2
5 mg dose
Drug: MEM 3454
5 mg dose
Experimental: 3
15 mg dose
Drug: MEM 3454
15 mg dose
Experimental: 4
50 mg dose
Drug: MEM 3454
50 mg dose
Placebo Comparator: 5
Placebo dose
Drug: Placebo for MEM 3454
Placebo dose

Primary Outcome Measures :
  1. Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454. [ Time Frame: Pre-dosing and Day 1 ]

Secondary Outcome Measures :
  1. • Investigate the safety and tolerability of MEM 3454 compared with placebo [ Time Frame: all time points ]
  2. • Determine whether MMN correlates with P50. [ Time Frame: Pre-dose and day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725855

Contact: Ann Olincy, MD, 303-315-5046

United States, Colorado
University of Colorado Health Sciences Center Not yet recruiting
Denver, Colorado, United States, 80262
Contact: Ann Olincy, MD    303-315-5046   
Principal Investigator: Ann Olincy, MD         
Sponsors and Collaborators
Memory Pharmaceuticals
Hoffmann-La Roche
Principal Investigator: Ann Olincy, MD, MPH University of Colorado, Denver

Responsible Party: Abdul Abdullah, MD, Project Medical Director, Memory Pharmaceuticals Corp. Identifier: NCT00725855     History of Changes
Other Study ID Numbers: MEM 3454-102
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: July 31, 2008
Last Verified: July 2008

Keywords provided by Memory Pharmaceuticals:
P50 Sensory Gating
Mismatched Negativity

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders