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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio.
Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 1 mg dose |
|
| 2 | Experimental | 5 mg dose |
|
| 3 | Experimental | 15 mg dose |
|
| 4 | Experimental | 50 mg dose |
|
| 5 | Placebo Comparator | Placebo dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEM 3454 | Drug | 1 mg dose |
| |
| MEM 3454 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the utility of P50 sensory gating as an efficacy biomarker for nicotinic alpha-7 agonist such as MEM 3454. | Pre-dosing and Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| • Investigate the safety and tolerability of MEM 3454 compared with placebo | all time points | |
| • Determine whether MMN correlates with P50. | Pre-dose and day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Olincy, MD, | Contact | 303-315-5046 | ann.olincy@uchsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ann Olincy, MD, MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17161386 | Background | Braff DL, Light GA, Swerdlow NR. Prepulse inhibition and P50 suppression are both deficient but not correlated in schizophrenia patients. Biol Psychiatry. 2007 May 15;61(10):1204-7. doi: 10.1016/j.biopsych.2006.08.015. Epub 2006 Dec 8. | |
| 16754836 | Background | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Drug |
5 mg dose |
|
| MEM 3454 | Drug | 15 mg dose |
|
| MEM 3454 | Drug | 50 mg dose |
|
| Placebo for MEM 3454 | Drug | Placebo dose |
|
| 12769624 | Background | Simosky JK, Stevens KE, Freedman R. Nicotinic agonists and psychosis. Curr Drug Targets CNS Neurol Disord. 2002 Apr;1(2):149-62. doi: 10.2174/1568007024606168. |