Clinical trial NCT00939783: An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease
Official title: An Open Label Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon (PF 01913539) In Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-07-15
Enrollment: 649
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 65 (end of treatment)
Secondary outcomes:
measure: Percentage of Participants With Abnormal Clinically Significant Vital Signs
timeFrame: Baseline up to Week 65 (end of treatment)
measure: Percentage of Participants With Abnormal Clinically Significant Laboratory Values
timeFrame: Baseline up to Week 65 (end of treatment)
measure: Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Week 65 (end of treatment)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Northport
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Oceanside
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Rosa
country: United States
facility: Pfizer Investigational Site
state: California
city: Pueblo
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hockessin
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Bradenton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Brooksville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Walton Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Maitland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Naples
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Plant City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Charlotte
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Burr Ridge
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Elk Grove Village
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Fort Wayne
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Greenfield
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Prairie Village
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Lake Charles
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Hyannis
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Olive Branch
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Great Falls
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Eatontown
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Oakhurst
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Amherst
country: United States
facility: Pfizer Investigational Site
state: New York
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Orchard Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Beaver
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bridgeville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Grove City
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Indiana
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Norristown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Scotland
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Upper St. Clair
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Murrells Inlet
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Orangeburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Carrollton
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Grand Prairie
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lake Jackson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Williamsburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Kirkland
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: La Crosse
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Medicine Hat
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Saint John
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Bay Roberts
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Kentville
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Pictou
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Burlington
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: L'Ancienne-Lorette
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St-Jean-sur-Richelieu
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: St. Leonard
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Cayey
country: Puerto Rico
facility: Pfizer Investigational Site
city: Cidra
country: Puerto Rico
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
city: San Juan
country: Puerto Rico
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: