An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease

NCT00939783 | Terminated Phase 3 Results DMC

• 1 other identifier: B1451029
• Study Type: interventional
• Target: 649
• Locations: 3 countries
• Sites: 105

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Adverse Events (AEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  Baseline up to Week 65 (end of treatment)

Secondary Outcomes (3)

• Percentage of Participants With Abnormal Clinically Significant Vital Signs

  Baseline up to Week 65 (end of treatment)

• Percentage of Participants With Abnormal Clinically Significant Laboratory Values

  Baseline up to Week 65 (end of treatment)

• Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings

  Baseline up to Week 65 (end of treatment)

Study Arms (1)

Dimebon 20 mg TID

EXPERIMENTAL

10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Drug: Dimebon

Interventions

Dimebon DRUG

Tablet for oral administration

Also known as: PF-01913539

Dimebon 20 mg TID

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of previous Phase 3 Dimebon study (B1451027).

You may not qualify if:

• Have any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Sponsors & Collaborators

• Pfizer: lead
• Medivation, Inc.: collaborator

Study Sites (105)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

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Northport, Alabama, 35476, United States

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Little Rock, Arkansas, 72205, United States

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Oceanside, California, 92056, United States

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San Diego, California, 92123, United States

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Santa Rosa, California, 95405, United States

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Pueblo, Colorado, 81001, United States

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Hockessin, Delaware, 19707, United States

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Bradenton, Florida, 34205, United States

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Brooksville, Florida, 34601, United States

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Clearwater, Florida, 33756, United States

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Daytona Beach, Florida, 32114, United States

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Fort Myers, Florida, 33912, United States

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Fort Walton Beach, Florida, 32547, United States

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Maitland, Florida, 32751, United States

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Melbourne, Florida, 32901, United States

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Naples, Florida, 34102, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32806, United States

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Plant City, Florida, 33563, United States

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Port Charlotte, Florida, 33952, United States

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St. Petersburg, Florida, 33709, United States

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St. Petersburg, Florida, 33713, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30308, United States

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Burr Ridge, Illinois, 60527, United States

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Elk Grove Village, Illinois, 60007, United States

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Elkhart, Indiana, 46514, United States

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Evansville, Indiana, 47714, United States

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Fort Wayne, Indiana, 46805, United States

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Greenfield, Indiana, 46140-2834, United States

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Prairie Village, Kansas, 66206, United States

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Wichita, Kansas, 67207, United States

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Lake Charles, Louisiana, 70601, United States

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New Orleans, Louisiana, 70114, United States

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Shreveport, Louisiana, 71105, United States

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Hyannis, Massachusetts, 02601, United States

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Flowood, Mississippi, 39232, United States

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Olive Branch, Mississippi, 38654, United States

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Springfield, Missouri, 65807, United States

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Great Falls, Montana, 59405, United States

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Eatontown, New Jersey, 07724, United States

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Oakhurst, New Jersey, 07755, United States

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Toms River, New Jersey, 08755, United States

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Albuquerque, New Mexico, 87109, United States

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Amherst, New York, 14226, United States

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Buffalo, New York, 14211, United States

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Buffalo, New York, 14215, United States

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Orchard Park, New York, 14127, United States

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Syracuse, New York, 13210, United States

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Charlotte, North Carolina, 28211, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58103, United States

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Fargo, North Dakota, 58104, United States

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Cincinnati, Ohio, 45227, United States

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Oklahoma City, Oklahoma, 73112, United States

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Portland, Oregon, 97210, United States

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Altoona, Pennsylvania, 16602, United States

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Beaver, Pennsylvania, 15009, United States

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Bridgeville, Pennsylvania, 15017, United States

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Grove City, Pennsylvania, 16127, United States

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Indiana, Pennsylvania, 15701, United States

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Norristown, Pennsylvania, 19403, United States

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Scotland, Pennsylvania, 17254, United States

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Upper Saint Clair, Pennsylvania, 15241, United States

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Charleston, South Carolina, 29425, United States

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Greer, South Carolina, 29651, United States

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Murrells Inlet, South Carolina, 29576, United States

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North Charleston, South Carolina, 29406, United States

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Orangeburg, South Carolina, 29118, United States

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Sioux Falls, South Dakota, 57105, United States

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Franklin, Tennessee, 37067, United States

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Knoxville, Tennessee, 37920, United States

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Carrollton, Texas, 75007, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76117, United States

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Grand Prairie, Texas, 75050, United States

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Lake Jackson, Texas, 77566, United States

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Williamsburg, Virginia, 23185, United States

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Kirkland, Washington, 98033, United States

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Spokane, Washington, 99216, United States

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Charleston, West Virginia, 25304, United States

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La Crosse, Wisconsin, 54601, United States

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Calgary, Alberta, T3C 3P1, Canada

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Medicine Hat, Alberta, T1B 4E7, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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Saint John, New Brunswick, E2L 3L6, Canada

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Bay Roberts, Newfoundland and Labrador, A0A 1G0, Canada

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Kentville, Nova Scotia, B4N 4K9, Canada

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Pictou, Nova Scotia, B0K 1H0, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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London, Ontario, N6A 4V2, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M6M 3Z5, Canada

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L'Ancienne-Lorette, Quebec, G2E 2X1, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Québec, Quebec, G2B 5S1, Canada

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Saint-Jean-sur-Richelieu, Quebec, J2W 1J1, Canada

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Saint-Léonard, Quebec, H1S 3A9, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Cayey, 00736, Puerto Rico

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Cidra, 00739, Puerto Rico

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San Juan, 00907, Puerto Rico

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San Juan, 00918, Puerto Rico

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

latrepirdine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This safety study did not specify primary or secondary outcome measures. Relevant summaries of all safety assessments are thus provided. Urine blood abnormalities seen are deemed due to interference with dipstick test by a metabolite of dimebon.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 15, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: November 14, 2012
• Results First Posted: November 14, 2012

Record last verified: 2012-10

Locations

CA (17); US (84); PR (4)