Clinical trial NCT00838110: A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Dimebon
Safety
Tolerability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-02-06
Enrollment: 742
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
timeFrame: Baseline up to Week 30 (follow-up)
measure: Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
timeFrame: Baseline up to Week 16 (follow-up)
measure: Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
timeFrame: Baseline up to Week 30 (follow-up)
measure: Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
timeFrame: Baseline up to Week 16 (follow-up)
measure: Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
timeFrame: Baseline up to Week 30 (follow-up)
measure: Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
timeFrame: Baseline up to Week 16 (follow-up)
measure: Percentage of Participants With Adverse Events (AEs) in Cohort 1
timeFrame: Baseline up to Week 30 (follow-up)
measure: Percentage of Participants With Adverse Events (AEs) in Cohort 2
timeFrame: Baseline up to Week 16 (follow-up)
Secondary outcomes:
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: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Destin
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: Fruitland Park
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: 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: Port Orange
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
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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: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: West Yarmouth
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: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
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
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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: 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: 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
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state: Pennsylvania
city: Beaver
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bridgeville
country: United States
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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: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Scotland
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Upper Saint 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: Nashville
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
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state: Texas
city: Grand Prairie
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
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
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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: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
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: Corunna
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: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
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: Rio Piedras
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: