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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Memory Pharmaceuticals.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Memory Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00725855
First received: July 29, 2008
Last updated: July 30, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Schizophrenia
Drug: MEM 3454
Drug: Placebo for MEM 3454
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Memory Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Investigate the safety and tolerability of MEM 3454 compared with placebo [ Time Frame: all time points ] [ Designated as safety issue: Yes ]
  • • Determine whether MMN correlates with P50. [ Time Frame: Pre-dose and day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725855

Contacts
Contact: Ann Olincy, MD, 303-315-5046 ann.olincy@uchsc.edu

Locations
United States, Colorado
University of Colorado Health Sciences Center Not yet recruiting
Denver, Colorado, United States, 80262
Contact: Ann Olincy, MD    303-315-5046    ann.olincy@uchsc.edu   
Principal Investigator: Ann Olincy, MD         
Sponsors and Collaborators
Memory Pharmaceuticals
Hoffmann-La Roche
Investigators
Principal Investigator: Ann Olincy, MD, MPH University of Colorado, Denver
  More Information

Publications:
Responsible Party: Abdul Abdullah, MD, Project Medical Director, Memory Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00725855     History of Changes
Other Study ID Numbers: MEM 3454-102
Study First Received: July 29, 2008
Last Updated: July 30, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Memory Pharmaceuticals:
Schizophrenia
P50 Sensory Gating
Mismatched Negativity

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 25, 2014