Clinical trial NCT00604760: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cognitive Impairment Associated With Schizophrenia
Lead sponsor: Memory Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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).

Primary outcomes:
measure: Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
timeFrame: Change from baseline at wk 8.
Secondary outcomes:
measure: Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10
timeFrame: Change from baseline - weeks 4 and 10
measure: Change from baseline on the various cognition tests at Weeks 4, 8 and 10
timeFrame: Change from baseline at Weeks 4, 8 and 10
measure: Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP
timeFrame: Change from baseline at weeks 8 and 10
measure: Adverse events
timeFrame: weeks 2, 4, 6, 8, 10
Other outcomes:
Locations:
city: Lemon Grove
country: United States
facility: Telecare-Cresta Loma
state: California
city: Newport Beach
country: United States
facility: Newport Bay Hospital
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: Pasadena
country: United States
facility: Pasadena Research Institute
state: California
city: Rosemead
country: United States
facility: BHC Alhambra Hospital
state: California
city: San Diego
country: United States
facility: California Clinical Trials Medical Group
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Santa Ana
country: United States
facility: Coastal Communities Hospital
state: California
city: Torrance
country: United States
facility: Collaborative NeuroScience Network, Inc.
state: California
city: Aventura
country: United States
facility: Aventura Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Fort Lauderdale Hospital
state: Florida
city: Miami
country: United States
facility: Aventura Hospital
state: Florida
city: Miami
country: United States
facility: TuKoi Clinical Research
state: Florida
city: North Miami
country: United States
facility: Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
state: Florida
city: North Miami
country: United States
facility: Scientific Clinical Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Berwyn
country: United States
facility: Berwyn Rehabilitation Center
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Behavioral Health Hospital
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Hoffman Estates
country: United States
facility: Chinmay K. Patel, DO
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Wichita
country: United States
facility: Clinical Research Institute
state: Kansas
city: Olive Branch
country: United States
facility: Parkwood Behavioral Health System
state: Mississippi
city: St. Louis
country: United States
facility: St. Louis Clinical Trials, LC
state: Missouri
city: Willingboro
country: United States
facility: CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
state: New Jersey
city: Willingboro
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Norristown
country: United States
facility: Arthur P. Noyes Research Foundation
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRC Worldwide, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Carolina Clinical Trials, Inc.
state: South Carolina
city: Madison
country: United States
facility: Centerstone
state: Tennessee
city: Memphis
country: United States
facility: Research Strategies of Memphis, LLC
state: Tennessee
city: Memphis
country: United States
facility: Vogelfanger and Struble Clinic
state: Tennessee
city: Memphis
country: United States
facility: Lakeside Behavioral Health System
state: Tennessee
city: Nashville
country: United States
facility: Centerstone - Ella Hayes Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Psychiatric Hospital
state: Tennessee
city: Nashville
country: United States
facility: Centerstone - Frank Luton Center
state: Tennessee
city: Austin
country: United States
facility: Texas NeuroRehab Center, Pecos Unit
state: Texas
city: Austin
country: United States
facility: Community Clinical Reserarch, Inc.
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Petersburg
country: United States
facility: Poplar Springs Hospital
state: Virginia
city: Richmond
country: United States
facility: International Clinical Research Associates, LLC
state: Virginia
city: Bothell
country: United States
facility: Pacific Institute of Medical Sciences
state: Washington
Study officials:
References:
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.
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.