Cognitive Impairment Associated With SchizophreniaPhase 2NCT00604760
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
A Phase 2 study testing MEM 3454 in people with Cognitive Impairment Associated With Schizophrenia, run by Memory Pharmaceuticals at 44 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cognitive Impairment Associated With Schizophrenia
- What is being tested?
- MEM 3454
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 44 sitesUnited States
- Study dates
- Dec 2007to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Texas NeuroRehab Center, Pecos Unit
Austin, Texas, 78745
Community Clinical Reserarch, Inc.
Austin, Texas, 78754
FutureSearch Trials
Austin, Texas, 78756
Aventura Hospital
Aventura, Florida, 33180
Berwyn Rehabilitation Center
Berwyn, Illinois, 60402
Pacific Institute of Medical Sciences
Bothell, Washington, 98011
Carolina Clinical Trials, Inc.
Charleston, South Carolina, 29405
Fort Lauderdale Hospital
Fort Lauderdale, Florida, 33301
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60169
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Chinmay K. Patel, DO
Hoffman Estates, Illinois, 60169
University Hills Clinical Research
Irving, Texas, 75062
Telecare-Cresta Loma
Lemon Grove, California, 91945
Centerstone
Madison, Tennessee, 37115
Research Strategies of Memphis, LLC
Memphis, Tennessee, 38117
Vogelfanger and Struble Clinic
Memphis, Tennessee, 38119
Lakeside Behavioral Health System
Memphis, Tennessee, 38133
Aventura Hospital
Miami, Florida, 33180
TuKoi Clinical Research
Miami, Florida, 33180
Centerstone - Ella Hayes Center
Nashville, Tennessee, 37208
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, 37212-8645
Centerstone - Frank Luton Center
Nashville, Tennessee, 37217
Newport Bay Hospital
Newport Beach, California, 92663
Arthur P. Noyes Research Foundation
Norristown, Pennsylvania, 19401
Professional Clinical Research, Inc. c/o Segal Institute for Clinical Research
North Miami, Florida, 33161
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
American Medical Research, Inc.
Oak Brook, Illinois, 60523
Excell Research
Oceanside, California, 92056
Sooner Clinical Research
Oklahoma City, Oklahoma, 73112
Parkwood Behavioral Health System
Olive Branch, Mississippi, 38654
Pasadena Research Institute
Pasadena, California, 91107
Poplar Springs Hospital
Petersburg, Virginia, 23805
CRC Worldwide, LLC
Philadelphia, Pennsylvania, 19139
International Clinical Research Associates, LLC
Richmond, Virginia, 23229
BHC Alhambra Hospital
Rosemead, California, 91770
California Clinical Trials Medical Group
San Diego, California, 92123
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
Coastal Communities Hospital
Santa Ana, California, 92704
St. Louis Clinical Trials, LC
St Louis, Missouri, 63118
Collaborative NeuroScience Network, Inc.
Torrance, California, 90502
Clinical Research Institute
Wichita, Kansas, 67207
CRI Worldwide, LLC at Lourdes Medical Center of Burlington County
Willingboro, New Jersey, 08046
CRI Worldwide, LLC
Willingboro, New Jersey, 08046
About this study
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
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).
- Being tested
- MEM 3454, Placebo for MEM 3454
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEM 3454Drug
Capsule 5 mg once a day
MEM 3454Drug
Capsule 15 mg once a day
MEM 3454Drug
Capsule 50 mg once a day
Placebo for MEM 3454Drug
Capsule once a day
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: MEM 3454 |
| B | Experimental | Not described Receives: Drug: MEM 3454 |
| C | Experimental | Not described Receives: Drug: MEM 3454 |
| D | Placebo comparator | Not described Receives: Drug: Placebo for MEM 3454 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
Measured: Change from baseline at wk 8.
Secondary outcomes (4)
Change from baseline in the total composite score of the MATRICS cognitive battery at Weeks 4 and 10
Measured: Change from baseline - weeks 4 and 10
Change from baseline on the various cognition tests at Weeks 4, 8 and 10
Measured: Change from baseline at Weeks 4, 8 and 10
Functional Assessments Change from baseline on the following tests at Week 8 and 10: UPSA-2 and PSP
Measured: Change from baseline at weeks 8 and 10
Adverse events
Measured: weeks 2, 4, 6, 8, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairment Associated With SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memory Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604760
- Sponsor's protocol ID
- MEM 3454-101
- Status last verified
- Dec 2008
- First submitted
- 17 Jan 2008
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15888422Olincy 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.
PubMed 16754836
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00604760
- Acronym / sponsor ID
- MEM 3454-101
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Memory PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Feb 2009 (estimated)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MEM 3454 |
| B | Experimental | Drug: MEM 3454 |
| C | Experimental | Drug: MEM 3454 |
| D | Placebo comparator | Drug: Placebo for MEM 3454 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEM 3454Capsule 5 mg once a day | Drug | A |
| MEM 3454Capsule 15 mg once a day | Drug | B |
| MEM 3454Capsule 50 mg once a day | Drug | C |
| Placebo for MEM 3454Capsule once a day | Drug | D |
Primary outcome
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8.
Time frame: Change from baseline at wk 8.
4 secondary outcomes
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
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
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
Adverse events
Time frame: weeks 2, 4, 6, 8, 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2008.
- Background: PubMed 15888422Buchanan 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.
- Background: PubMed 16754836Olincy 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.
- MATRICS TestsLink provided by the sponsor.
Related trials for Cognitive Impairment Associated With Schizophrenia
Recruiting
Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use
Psychotic Disorders, Cannabis Use Disorder
Not yet recruiting
tDCS for Cognitive Impairment Associated With Recent-onset Schizophrenia
Schizophrenia, Psychotic Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEM 3454 in people with Cognitive Impairment Associated With Schizophrenia, run by Memory Pharmaceuticals at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the total composite score of the MATRICS cognitive battery at week 8. (time frame: Change from baseline at wk 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00604760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2008.