Study to Evaluate the Safety and Efficacy of MEM 3454 as... | NCT00604760

Studies
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

NCT00604760

Sponsor

Memory Pharmaceuticals

Status

Unknown status

Last Update Posted

Dec 8, 2008Estimated

Enrollment

160Estimated

Phase

Phase 2

Conditions

Cognitive Impairment Associated With Schizophrenia

Interventions

MEM 3454
MEM 3454
MEM 3454
Placebo for MEM 3454

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

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

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Feb 2009Estimated

Completion Date

Not provided

First Submitted Date

Jan 17, 2008

First Submission Date that Met QC Criteria

Jan 29, 2008

First Posted Date

Jan 30, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2008

Last Update Posted Date

Dec 8, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A	Experimental	Drug: MEM 3454
B	Experimental	Drug: MEM 3454
C	Experimental	Drug: MEM 3454
D	Placebo Comparator	Drug: Placebo for MEM 3454

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MEM 3454	Drug	Capsule 5 mg once a day	A
MEM 3454

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.		Change from baseline at wk 8.

Secondary Outcomes

Measure	Description	Time Frame
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
Change from baseline on the various cognition tests at Weeks 4, 8 and 10		Change from baseline at Weeks 4, 8 and 10

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Telecare-Cresta Loma		Lemon Grove	California	91945	United States
Newport Bay Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15888422	Background	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.
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