Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
Study NCT ID:
NCT00604760
Status:
UNKNOWN
Last Update Posted:
2008-12-08
First Post:
2008-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'lastUpdateSubmitDate': '2008-12-05', 'studyFirstSubmitDate': '2008-01-17', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.', 'timeFrame': 'Change from baseline at wk 8.'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment Associated With Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '15888422', 'type': 'BACKGROUND', '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.'}, {'pmid': '16754836', 'type': 'BACKGROUND', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.matricsinc.org/', 'label': 'MATRICS Tests'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia (any subtype), assessed using a structured interview.\n* At least one month on the same dose of antipsychotic medication.\n* Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks.\n* Able to provide informed consent.\n* Fluent in English.\n* Smokers and non-smokers.\n\nExclusion Criteria:\n\n* First 3 years of schizophrenia diagnosis.\n* Current risk of suicide, or history of suicidal behavior within the last 6 months.\n* Hospitalized for psychiatric symptoms in the past 3 months.\n* Other psychiatric diagnoses.\n* Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according.\n* Nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).'}, 'identificationModule': {'nctId': 'NCT00604760', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Memory Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MEM 3454-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: MEM 3454']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: MEM 3454']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'interventionNames': ['Drug: MEM 3454']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'interventionNames': ['Drug: Placebo for MEM 3454']}], 'interventions': [{'name': 'MEM 3454', 'type': 'DRUG', 'description': 'Capsule 5 mg once a day', 'armGroupLabels': ['A']}, {'name': 'MEM 3454', 'type': 'DRUG', 'description': 'Capsule 15 mg once a day', 'armGroupLabels': ['B']}, {'name': 'MEM 3454', 'type': 'DRUG', 'description': 'Capsule 50 mg once a day', 'armGroupLabels': ['C']}, {'name': 'Placebo for MEM 3454', 'type': 'DRUG', 'description': 'Capsule once a day', 'armGroupLabels': ['D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91945', 'city': 'Lemon Grove', 'state': 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