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| Sponsor: | Pfizer |
|---|---|
| Collaborator: |
Medivation, Inc. |
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00838110 |
Purpose
This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Dimebon Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease |
| Estimated Enrollment: | 750 |
| Study Start Date: | February 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Dimebon 20 mg TID (Cohort 1): Experimental |
Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 26
|
| Placebo TID (Cohort 1): Placebo Comparator |
Drug: Placebo
10 mg TID for week 1 followed by 20 mg TID through Week 26
|
| Dimebon 20 mg TID (Cohort 2): Experimental |
Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 12
|
| Placebo TID (Cohort 2): Placebo Comparator |
Drug: Placebo
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| Pfizer Investigational Site | |
| Northport, Alabama, United States, 35476 | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Pfizer Investigational Site | |
| Oceanside, California, United States, 92056 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92123 | |
| Pfizer Investigational Site | |
| Santa Rosa, California, United States, 95405 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Pueblo, Colorado, United States, 81001 | |
| United States, Delaware | |
| Pfizer Investigational Site | |
| Hockessin, Delaware, United States, 19707 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Bradenton, Florida, United States, 34205 | |
| Pfizer Investigational Site | |
| Brooksville, Florida, United States, 34601 | |
| Pfizer Investigational Site | |
| Clearwater, Florida, United States, 33756 | |
| Pfizer Investigational Site | |
| Daytona Beach, Florida, United States, 32114 | |
| Pfizer Investigational Site | |
| Daytona Beach, Florida, United States, 32117 | |
| Pfizer Investigational Site | |
| Destin, Florida, United States, 32541 | |
| Pfizer Investigational Site | |
| Fort Myers, Florida, United States, 33912 | |
| Pfizer Investigational Site | |
| Fort Walton Beach, Florida, United States, 32547 | |
| Pfizer Investigational Site | |
| Fruitland Park, Florida, United States, 34731 | |
| Pfizer Investigational Site | |
| Melbourne, Florida, United States, 32901 | |
| Pfizer Investigational Site | |
| Naples, Florida, United States, 34102 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34474 | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34471 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| Pfizer Investigational Site | |
| Plant City, Florida, United States, 33563 | |
| Pfizer Investigational Site | |
| Port Charlotte, Florida, United States, 33952 | |
| Pfizer Investigational Site | |
| Port Orange, Florida, United States, 32127 | |
| Pfizer Investigational Site | |
| St Petersburg, Florida, United States, 33713 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33709 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33606 | |
| Pfizer Investigational Site | |
| Tampa, Florida, United States, 33629 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Burr Ridge, Illinois, United States, 60527 | |
| Pfizer Investigational Site | |
| Elk Grove Village, Illinois, United States, 60007 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Elkhart, Indiana, United States, 46514 | |
| Pfizer Investigational Site | |
| Evansville, Indiana, United States, 47714 | |
| Pfizer Investigational Site | |
| Fort Wayne, Indiana, United States, 46805 | |
| Pfizer Investigational Site | |
| Greenfield, Indiana, United States, 46140-2834 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Prairie Village, Kansas, United States, 66206 | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Lake Charles, Louisiana, United States, 70601 | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71105 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| West Yarmouth, Massachusetts, United States, 02763 | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Flowood, Mississippi, United States, 39232 | |
| Pfizer Investigational Site | |
| Olive Branch, Mississippi, United States, 38654 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| Kansas City, Missouri, United States, 64114 | |
| Pfizer Investigational Site | |
| Springfield, Missouri, United States, 65807 | |
| United States, Montana | |
| Pfizer Investigational Site | |
| Great Falls, Montana, United States, 59405 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Eatontown, New Jersey, United States, 07724 | |
| Pfizer Investigational Site | |
| Oakhurst, New Jersey, United States, 07755 | |
| Pfizer Investigational Site | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New Mexico | |
| Pfizer Investigational Site | |
| Albuquerque, New Mexico, United States, 87109 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Amherst, New York, United States, 14226 | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States, 14215 | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States, 14211 | |
| Pfizer Investigational Site | |
| Orchard Park, New York, United States, 14127 | |
| Pfizer Investigational Site | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Charlotte, North Carolina, United States, 28211 | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27607 | |
| Pfizer Investigational Site | |
| Raleigh, North Carolina, United States, 27612 | |
| Pfizer Investigational Site | |
| Winston Salem, North Carolina, United States, 27103 | |
| Pfizer Investigational Site | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, North Dakota | |
| Pfizer Investigational Site | |
| Fargo, North Dakota, United States, 58103 | |
| Pfizer Investigational Site | |
| Fargo, North Dakota, United States, 58104 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45227 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Altoona, Pennsylvania, United States, 16602 | |
| Pfizer Investigational Site | |
| Beaver, Pennsylvania, United States, 15009 | |
| Pfizer Investigational Site | |
| Bridgeville, Pennsylvania, United States, 15017 | |
| Pfizer Investigational Site | |
| Grove City, Pennsylvania, United States, 16127 | |
| Pfizer Investigational Site | |
| Indiana, Pennsylvania, United States, 15701 | |
| Pfizer Investigational Site | |
| Norristown, Pennsylvania, United States, 19401 | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| Pfizer Investigational Site | |
| Scotland, Pennsylvania, United States, 17254 | |
| Pfizer Investigational Site | |
| Upper St. Clair, Pennsylvania, United States, 15241 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Charleston, South Carolina, United States, 29425 | |
| Pfizer Investigational Site | |
| Greer, South Carolina, United States, 29651 | |
| Pfizer Investigational Site | |
| Murrells Inlet, South Carolina, United States, 29576 | |
| Pfizer Investigational Site | |
| North Charleston, South Carolina, United States, 29406-6076 | |
| Pfizer Investigational Site | |
| Orangeburg, South Carolina, United States, 29118 | |
| United States, South Dakota | |
| Pfizer Investigational Site | |
| Sioux Falls, South Dakota, United States, 57105 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Franklin, Tennessee, United States, 37067 | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Carrollton, Texas, United States, 75007 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76117 | |
| Pfizer Investigational Site | |
| Grand Prairie, Texas, United States, 75050 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77074 | |
| Pfizer Investigational Site | |
| Lake Jackson, Texas, United States, 77566 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Williamsburg, Virginia, United States, 23185 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Kirkland, Washington, United States, 98033 | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99216 | |
| United States, West Virginia | |
| Pfizer Investigational Site | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| La Crosse, Wisconsin, United States, 54650 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T3C 3P1 | |
| Pfizer Investigational Site | |
| Medicine Hat, Alberta, Canada, T1B 4E7 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Surrey, British Columbia, Canada, V4A 2H9 | |
| Pfizer Investigational Site | |
| Victoria, British Columbia, Canada, V8R 1J8 | |
| Canada, New Brunswick | |
| Pfizer Investigational Site | |
| Saint John, New Brunswick, Canada, E2L 3L6 | |
| Canada, Newfoundland and Labrador | |
| Pfizer Investigational Site | |
| Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0 | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Kentville, Nova Scotia, Canada, B4N 4K9 | |
| Pfizer Investigational Site | |
| Pictou, Nova Scotia, Canada, B0K 1H0 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Burlington, Ontario, Canada, L7M 4Y1 | |
| Pfizer Investigational Site | |
| Corunna, Ontario, Canada, N0N 1G0 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 4V2 | |
| Pfizer Investigational Site | |
| Sarnia, Ontario, Canada, N7T 4X3 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M6M 3Z5 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| Pfizer Investigational Site | |
| L'Ancienne-Lorette, Quebec, Canada, G2E 2X1 | |
| Pfizer Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Pfizer Investigational Site | |
| St-Jean-sur-Richelieu, Quebec, Canada, J2W 1J1 | |
| Pfizer Investigational Site | |
| St. Leonard, Quebec, Canada, H1S 3A9 | |
| Canada | |
| Pfizer Investigational Site | |
| Quebec, Canada, G2B 5S1 | |
| Pfizer Investigational Site | |
| Quebec, Canada, G1J 1Z4 | |
| Puerto Rico | |
| Pfizer Investigational Site | |
| Cayey, Puerto Rico, 00736 | |
| Pfizer Investigational Site | |
| Cidra, Puerto Rico, 00739 | |
| Pfizer Investigational Site | |
| Rio Piedras, Puerto Rico, 00924 | |
| Pfizer Investigational Site | |
| San Juan, Puerto Rico, 00918 | |
| Pfizer Investigational Site | |
| San Juan, Puerto Rico, 00907 | |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
| Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
| ClinicalTrials.gov Identifier: | NCT00838110 History of Changes |
| Other Study ID Numbers: | B1451027 |
| Study First Received: | February 5, 2009 |
| Last Updated: | March 3, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's Disease Dimebon Safety Tolerability |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |