A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00838110
• Other study ID #: B1451027
• Status: Completed
• Phase: Phase 3
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 26
• Placebo
10 mg TID for week 1 followed by 20 mg TID through Week 26
• Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 12
• Placebo
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Burlington	Ontario
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Corunna	Ontario
Canada	Pfizer Investigational Site	Greenfield Park	Quebec
Canada	Pfizer Investigational Site	Kentville	Nova Scotia
Canada	Pfizer Investigational Site	L'Ancienne-Lorette	Quebec
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Medicine Hat	Alberta
Canada	Pfizer Investigational Site	Pictou	Nova Scotia
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Saint John	New Brunswick
Canada	Pfizer Investigational Site	Sarnia	Ontario
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	St-Jean-sur-Richelieu	Quebec
Canada	Pfizer Investigational Site	St. Leonard	Quebec
Canada	Pfizer Investigational Site	Surrey	British Columbia
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Puerto Rico	Pfizer Investigational Site	Cayey
Puerto Rico	Pfizer Investigational Site	Cidra
Puerto Rico	Pfizer Investigational Site	Rio Piedras
Puerto Rico	Pfizer Investigational Site	San Juan
Puerto Rico	Pfizer Investigational Site	San Juan
United States	Pfizer Investigational Site	Albuquerque	New Mexico
United States	Pfizer Investigational Site	Altoona	Pennsylvania
United States	Pfizer Investigational Site	Amherst	New York
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Beaver	Pennsylvania
United States	Pfizer Investigational Site	Bradenton	Florida
United States	Pfizer Investigational Site	Bridgeville	Pennsylvania
United States	Pfizer Investigational Site	Brooksville	Florida
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Buffalo	New York
United States	Pfizer Investigational Site	Burr Ridge	Illinois
United States	Pfizer Investigational Site	Carrollton	Texas
United States	Pfizer Investigational Site	Charleston	West Virginia
United States	Pfizer Investigational Site	Charleston	South Carolina
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Daytona Beach	Florida
United States	Pfizer Investigational Site	Destin	Florida
United States	Pfizer Investigational Site	Eatontown	New Jersey
United States	Pfizer Investigational Site	Elk Grove Village	Illinois
United States	Pfizer Investigational Site	Elkhart	Indiana
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Fargo	North Dakota
United States	Pfizer Investigational Site	Flowood	Mississippi
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Fort Walton Beach	Florida
United States	Pfizer Investigational Site	Fort Wayne	Indiana
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Franklin	Tennessee
United States	Pfizer Investigational Site	Fruitland Park	Florida
United States	Pfizer Investigational Site	Grand Prairie	Texas
United States	Pfizer Investigational Site	Great Falls	Montana
United States	Pfizer Investigational Site	Greenfield	Indiana
United States	Pfizer Investigational Site	Greer	South Carolina
United States	Pfizer Investigational Site	Grove City	Pennsylvania
United States	Pfizer Investigational Site	Hockessin	Delaware
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Indiana	Pennsylvania
United States	Pfizer Investigational Site	Kansas City	Missouri
United States	Pfizer Investigational Site	Kirkland	Washington
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	La Crosse	Wisconsin
United States	Pfizer Investigational Site	Lake Charles	Louisiana
United States	Pfizer Investigational Site	Lake Jackson	Texas
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Murrells Inlet	South Carolina
United States	Pfizer Investigational Site	Naples	Florida
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Norristown	Pennsylvania
United States	Pfizer Investigational Site	North Charleston	South Carolina
United States	Pfizer Investigational Site	Northport	Alabama
United States	Pfizer Investigational Site	Oakhurst	New Jersey
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Ocala	Florida
United States	Pfizer Investigational Site	Oceanside	California
United States	Pfizer Investigational Site	Oklahoma City	Oklahoma
United States	Pfizer Investigational Site	Olive Branch	Mississippi
United States	Pfizer Investigational Site	Orangeburg	South Carolina
United States	Pfizer Investigational Site	Orchard Park	New York
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Plant City	Florida
United States	Pfizer Investigational Site	Port Charlotte	Florida
United States	Pfizer Investigational Site	Port Orange	Florida
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Prairie Village	Kansas
United States	Pfizer Investigational Site	Pueblo	Colorado
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Raleigh	North Carolina
United States	Pfizer Investigational Site	Saint Petersburg	Florida
United States	Pfizer Investigational Site	Saint Petersburg	Florida
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Santa Rosa	California
United States	Pfizer Investigational Site	Scotland	Pennsylvania
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	Sioux Falls	South Dakota
United States	Pfizer Investigational Site	Spokane	Washington
United States	Pfizer Investigational Site	Springfield	Missouri
United States	Pfizer Investigational Site	Syracuse	New York
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Toms River	New Jersey
United States	Pfizer Investigational Site	Upper Saint Clair	Pennsylvania
United States	Pfizer Investigational Site	West Yarmouth	Massachusetts
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Williamsburg	Virginia
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Medivation, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1	Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values: less than (<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (>=) 30 mmHg from baseline; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).	Baseline up to Week 30 (follow-up)
Primary	Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2	Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.	Baseline up to Week 16 (follow-up)
Primary	Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1	Abnormal ECG findings included maximum value of >=300 millisecond (msec), maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval (int); maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).	Baseline up to Week 30 (follow-up)
Primary	Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2	Abnormal ECG findings included maximum value of >=300 msec, maximum increase of >=25% for baseline value of >200 msec and maximum increase of >=50% for baseline value of <=200 msec for PR interval; maximum value of >=200 msec, maximum increase of >=25% for baseline value of >100 msec and maximum increase of >=50% for baseline value of <=100 msec for QRS interval; maximum value of >=500 msec for QT interval; maximum value of 450 to <480, 480 to <500 and >=500 msec, increase of >=30 to <60 and >=60 msec for QT interval corrected using Fridericia's formula (QTcF interval).	Baseline up to Week 16 (follow-up)
Primary	Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1	For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.	Baseline up to Week 30 (follow-up)
Primary	Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2	For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.	Baseline up to Week 16 (follow-up)
Primary	Percentage of Participants With Adverse Events (AEs) in Cohort 1	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 30 (follow-up)
Primary	Percentage of Participants With Adverse Events (AEs) in Cohort 2	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 16 (follow-up)

External Links

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