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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

Primary Purpose

Cognitive Impairment Associated With Schizophrenia

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MEM 3454
MEM 3454
MEM 3454
Placebo for MEM 3454
Sponsored by
Memory Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment Associated With Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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).

Sites / Locations

  • Telecare-Cresta Loma
  • Newport Bay Hospital
  • Excell Research
  • Pasadena Research Institute
  • BHC Alhambra Hospital
  • California Clinical Trials Medical Group
  • Neuropsychiatric Research Center of Orange County
  • Coastal Communities Hospital
  • Collaborative NeuroScience Network, Inc.
  • Aventura Hospital
  • Fort Lauderdale Hospital
  • Aventura Hospital
  • TuKoi Clinical Research
  • Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
  • Scientific Clinical Research, Inc.
  • Atlanta Center for Medical Research
  • Berwyn Rehabilitation Center
  • Alexian Brothers Behavioral Health Hospital
  • Alexian Brothers Center for Psychiatric Research
  • Chinmay K. Patel, DO
  • American Medical Research, Inc.
  • Clinical Research Institute
  • Parkwood Behavioral Health System
  • St. Louis Clinical Trials, LC
  • CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
  • CRI Worldwide, LLC
  • Sooner Clinical Research
  • Arthur P. Noyes Research Foundation
  • CRC Worldwide, LLC
  • Carolina Clinical Trials, Inc.
  • Centerstone
  • Research Strategies of Memphis, LLC
  • Vogelfanger and Struble Clinic
  • Lakeside Behavioral Health System
  • Centerstone - Ella Hayes Center
  • Vanderbilt Psychiatric Hospital
  • Centerstone - Frank Luton Center
  • Texas NeuroRehab Center, Pecos Unit
  • Community Clinical Reserarch, Inc.
  • FutureSearch Trials
  • University Hills Clinical Research
  • Poplar Springs Hospital
  • International Clinical Research Associates, LLC
  • Pacific Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A

B

C

D

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2008
Last Updated
December 5, 2008
Sponsor
Memory Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00604760
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memory Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment Associated With Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Title
D
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MEM 3454
Intervention Description
Capsule 5 mg once a day
Intervention Type
Drug
Intervention Name(s)
MEM 3454
Intervention Description
Capsule 15 mg once a day
Intervention Type
Drug
Intervention Name(s)
MEM 3454
Intervention Description
Capsule 50 mg once a day
Intervention Type
Drug
Intervention Name(s)
Placebo for MEM 3454
Intervention Description
Capsule once a day
Primary Outcome Measure Information:
Title
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
Time Frame
Change from baseline at wk 8.
Secondary Outcome Measure Information:
Title
Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10
Time Frame
Change from baseline - weeks 4 and 10
Title
Change from baseline on the various cognition tests at Weeks 4, 8 and 10
Time Frame
Change from baseline at Weeks 4, 8 and 10
Title
Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP
Time Frame
Change from baseline at weeks 8 and 10
Title
Adverse events
Time Frame
weeks 2, 4, 6, 8, 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Telecare-Cresta Loma
City
Lemon Grove
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
Newport Bay Hospital
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Excell Research
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Pasadena Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
BHC Alhambra Hospital
City
Rosemead
State/Province
California
ZIP/Postal Code
91770
Country
United States
Facility Name
California Clinical Trials Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Coastal Communities Hospital
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Collaborative NeuroScience Network, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Aventura Hospital
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Fort Lauderdale Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33301
Country
United States
Facility Name
Aventura Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
TuKoi Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Scientific Clinical Research, Inc.
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Berwyn Rehabilitation Center
City
Berwyn
State/Province
Illinois
ZIP/Postal Code
60402
Country
United States
Facility Name
Alexian Brothers Behavioral Health Hospital
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Chinmay K. Patel, DO
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
American Medical Research, Inc.
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Clinical Research Institute
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Parkwood Behavioral Health System
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
St. Louis Clinical Trials, LC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
CRI Worldwide, LLC
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Arthur P. Noyes Research Foundation
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
CRC Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Carolina Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Centerstone
City
Madison
State/Province
Tennessee
ZIP/Postal Code
37115
Country
United States
Facility Name
Research Strategies of Memphis, LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Vogelfanger and Struble Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Lakeside Behavioral Health System
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38133
Country
United States
Facility Name
Centerstone - Ella Hayes Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37208
Country
United States
Facility Name
Vanderbilt Psychiatric Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-8645
Country
United States
Facility Name
Centerstone - Frank Luton Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37217
Country
United States
Facility Name
Texas NeuroRehab Center, Pecos Unit
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Community Clinical Reserarch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Poplar Springs Hospital
City
Petersburg
State/Province
Virginia
ZIP/Postal Code
23805
Country
United States
Facility Name
International Clinical Research Associates, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Pacific Institute of Medical Sciences
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15888422
Citation
Buchanan RW, Davis M, Goff D, Green MF, Keefe RS, Leon AC, Nuechterlein KH, Laughren T, Levin R, Stover E, Fenton W, Marder SR. A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia. Schizophr Bull. 2005 Jan;31(1):5-19. doi: 10.1093/schbul/sbi020. Epub 2005 Feb 16.
Results Reference
background
PubMed Identifier
16754836
Citation
Olincy A, Harris JG, Johnson LL, Pender V, Kongs S, Allensworth D, Ellis J, Zerbe GO, Leonard S, Stevens KE, Stevens JO, Martin L, Adler LE, Soti F, Kem WR, Freedman R. Proof-of-concept trial of an alpha7 nicotinic agonist in schizophrenia. Arch Gen Psychiatry. 2006 Jun;63(6):630-8. doi: 10.1001/archpsyc.63.6.630.
Results Reference
background
Links:
URL
http://www.matricsinc.org/
Description
MATRICS Tests

Learn more about this trial

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

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