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A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
This study has been completed.
First Received: February 5, 2009   Last Updated: March 3, 2010   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • ECG's [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
  • Clinical Chemistry / Hematology [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

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
Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease.
  • MMSE 12-26 inclusive.
  • If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
  • If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Exclusion Criteria:

  • Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
  • Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
  • Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
  • Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838110

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Locations
United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
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Northport, Alabama, United States, 35476
United States, Arkansas
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Little Rock, Arkansas, United States, 72205
United States, California
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Oceanside, California, United States, 92056
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San Diego, California, United States, 92123
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Santa Rosa, California, United States, 95405
United States, Colorado
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Pueblo, Colorado, United States, 81001
United States, Delaware
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Hockessin, Delaware, United States, 19707
United States, Florida
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Bradenton, Florida, United States, 34205
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Brooksville, Florida, United States, 34601
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Clearwater, Florida, United States, 33756
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Daytona Beach, Florida, United States, 32114
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Daytona Beach, Florida, United States, 32117
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Destin, Florida, United States, 32541
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Fort Myers, Florida, United States, 33912
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Fort Walton Beach, Florida, United States, 32547
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Fruitland Park, Florida, United States, 34731
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Melbourne, Florida, United States, 32901
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Naples, Florida, United States, 34102
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Ocala, Florida, United States, 34474
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Ocala, Florida, United States, 34471
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Orlando, Florida, United States, 32806
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Plant City, Florida, United States, 33563
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Port Charlotte, Florida, United States, 33952
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Port Orange, Florida, United States, 32127
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St Petersburg, Florida, United States, 33713
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St. Petersburg, Florida, United States, 33709
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Tampa, Florida, United States, 33606
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Tampa, Florida, United States, 33629
United States, Georgia
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Atlanta, Georgia, United States, 30308
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Burr Ridge, Illinois, United States, 60527
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Elk Grove Village, Illinois, United States, 60007
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Elkhart, Indiana, United States, 46514
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Evansville, Indiana, United States, 47714
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Fort Wayne, Indiana, United States, 46805
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Greenfield, Indiana, United States, 46140-2834
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Prairie Village, Kansas, United States, 66206
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Wichita, Kansas, United States, 67207
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Lake Charles, Louisiana, United States, 70601
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Shreveport, Louisiana, United States, 71105
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West Yarmouth, Massachusetts, United States, 02763
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Flowood, Mississippi, United States, 39232
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Olive Branch, Mississippi, United States, 38654
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Kansas City, Missouri, United States, 64114
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Springfield, Missouri, United States, 65807
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Great Falls, Montana, United States, 59405
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Eatontown, New Jersey, United States, 07724
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Oakhurst, New Jersey, United States, 07755
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Toms River, New Jersey, United States, 08755
United States, New Mexico
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Albuquerque, New Mexico, United States, 87109
United States, New York
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Amherst, New York, United States, 14226
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Buffalo, New York, United States, 14215
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Buffalo, New York, United States, 14211
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Orchard Park, New York, United States, 14127
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Syracuse, New York, United States, 13210
United States, North Carolina
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Charlotte, North Carolina, United States, 28211
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Raleigh, North Carolina, United States, 27607
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Raleigh, North Carolina, United States, 27612
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Winston Salem, North Carolina, United States, 27103
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Winston-Salem, North Carolina, United States, 27103
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Fargo, North Dakota, United States, 58103
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Fargo, North Dakota, United States, 58104
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Cincinnati, Ohio, United States, 45227
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Oklahoma City, Oklahoma, United States, 73112
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Portland, Oregon, United States, 97210
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Altoona, Pennsylvania, United States, 16602
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Beaver, Pennsylvania, United States, 15009
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Bridgeville, Pennsylvania, United States, 15017
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Grove City, Pennsylvania, United States, 16127
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Indiana, Pennsylvania, United States, 15701
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Norristown, Pennsylvania, United States, 19401
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Pittsburgh, Pennsylvania, United States, 15241
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Scotland, Pennsylvania, United States, 17254
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Upper St. Clair, Pennsylvania, United States, 15241
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Charleston, South Carolina, United States, 29425
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Greer, South Carolina, United States, 29651
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Murrells Inlet, South Carolina, United States, 29576
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North Charleston, South Carolina, United States, 29406-6076
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Orangeburg, South Carolina, United States, 29118
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
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Franklin, Tennessee, United States, 37067
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Knoxville, Tennessee, United States, 37920
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Nashville, Tennessee, United States, 37203
United States, Texas
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Carrollton, Texas, United States, 75007
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Fort Worth, Texas, United States, 76104
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Fort Worth, Texas, United States, 76117
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Grand Prairie, Texas, United States, 75050
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Houston, Texas, United States, 77074
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Lake Jackson, Texas, United States, 77566
United States, Virginia
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Williamsburg, Virginia, United States, 23185
United States, Washington
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Kirkland, Washington, United States, 98033
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Spokane, Washington, United States, 99216
United States, West Virginia
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Charleston, West Virginia, United States, 25304
United States, Wisconsin
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La Crosse, Wisconsin, United States, 54650
Canada, Alberta
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Calgary, Alberta, Canada, T3C 3P1
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Medicine Hat, Alberta, Canada, T1B 4E7
Canada, British Columbia
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Surrey, British Columbia, Canada, V4A 2H9
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Victoria, British Columbia, Canada, V8R 1J8
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Saint John, New Brunswick, Canada, E2L 3L6
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Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
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Kentville, Nova Scotia, Canada, B4N 4K9
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Pictou, Nova Scotia, Canada, B0K 1H0
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Burlington, Ontario, Canada, L7M 4Y1
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Corunna, Ontario, Canada, N0N 1G0
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Toronto, Ontario, Canada, M6M 3Z5
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L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
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Sherbrooke, Quebec, Canada, J1H 1Z1
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St-Jean-sur-Richelieu, Quebec, Canada, J2W 1J1
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St. Leonard, Quebec, Canada, H1S 3A9
Canada
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Quebec, Canada, G2B 5S1
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Quebec, Canada, G1J 1Z4
Puerto Rico
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Cayey, Puerto Rico, 00736
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Cidra, Puerto Rico, 00739
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Rio Piedras, Puerto Rico, 00924
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San Juan, Puerto Rico, 00918
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San Juan, Puerto Rico, 00907
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Keywords provided by Pfizer:
Alzheimer's Disease
Dimebon
Safety
Tolerability

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 01, 2010