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

Cognitive Impairment Associated With Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00604760
• Other study ID #: MEM 3454-101
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 17, 2008
• Last updated: December 5, 2008
• Start date: December 2007

Study information

• Verified date: December 2008
• Source: Memory Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment Associated With Schizophrenia
• Schizophrenia

Intervention

Drug:
• MEM 3454
Capsule 5 mg once a day
• MEM 3454
Capsule 15 mg once a day
• MEM 3454
Capsule 50 mg once a day
• Placebo for MEM 3454
Capsule once a day

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Community Clinical Reserarch, Inc.	Austin	Texas
United States	FutureSearch Trials	Austin	Texas
United States	Texas NeuroRehab Center, Pecos Unit	Austin	Texas
United States	Aventura Hospital	Aventura	Florida
United States	Berwyn Rehabilitation Center	Berwyn	Illinois
United States	Pacific Institute of Medical Sciences	Bothell	Washington
United States	Carolina Clinical Trials, Inc.	Charleston	South Carolina
United States	Fort Lauderdale Hospital	Fort Lauderdale	Florida
United States	Alexian Brothers Behavioral Health Hospital	Hoffman Estates	Illinois
United States	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois
United States	Chinmay K. Patel, DO	Hoffman Estates	Illinois
United States	University Hills Clinical Research	Irving	Texas
United States	Telecare-Cresta Loma	Lemon Grove	California
United States	Centerstone	Madison	Tennessee
United States	Lakeside Behavioral Health System	Memphis	Tennessee
United States	Research Strategies of Memphis, LLC	Memphis	Tennessee
United States	Vogelfanger and Struble Clinic	Memphis	Tennessee
United States	Aventura Hospital	Miami	Florida
United States	TuKoi Clinical Research	Miami	Florida
United States	Centerstone - Ella Hayes Center	Nashville	Tennessee
United States	Centerstone - Frank Luton Center	Nashville	Tennessee
United States	Vanderbilt Psychiatric Hospital	Nashville	Tennessee
United States	Newport Bay Hospital	Newport Beach	California
United States	Arthur P. Noyes Research Foundation	Norristown	Pennsylvania
United States	Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research	North Miami	Florida
United States	Scientific Clinical Research, Inc.	North Miami	Florida
United States	American Medical Research, Inc.	Oak Brook	Illinois
United States	Excell Research	Oceanside	California
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
United States	Parkwood Behavioral Health System	Olive Branch	Mississippi
United States	Pasadena Research Institute	Pasadena	California
United States	Poplar Springs Hospital	Petersburg	Virginia
United States	CRC Worldwide, LLC	Philadelphia	Pennsylvania
United States	International Clinical Research Associates, LLC	Richmond	Virginia
United States	BHC Alhambra Hospital	Rosemead	California
United States	California Clinical Trials Medical Group	San Diego	California
United States	Coastal Communities Hospital	Santa Ana	California
United States	Neuropsychiatric Research Center of Orange County	Santa Ana	California
United States	St. Louis Clinical Trials, LC	St. Louis	Missouri
United States	Collaborative NeuroScience Network, Inc.	Torrance	California
United States	Clinical Research Institute	Wichita	Kansas
United States	CRI Worldwide, LLC	Willingboro	New Jersey
United States	CRI Worldwide, LLC at Lourdes Medical Center of Burlington County	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Memory Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2005 Feb 16. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.		Change from baseline at wk 8.	No
Secondary	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	No
Secondary	Change from baseline on the various cognition tests at Weeks 4, 8 and 10		Change from baseline at Weeks 4, 8 and 10	No
Secondary	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	No
Secondary	Adverse events		weeks 2, 4, 6, 8, 10	Yes

External Links

•   MATRICS Tests