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

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

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

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Dimebon

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.

• Study Type: Interventional
• Enrollment (Actual): 649
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1J 1Z4
    • Pfizer Investigational Site
  • Quebec, Canada, G2B 5S1
    • Pfizer Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T3C 3P1
      • Pfizer Investigational Site
    • Medicine Hat, Alberta, Canada, T1B 4E7
      • Pfizer Investigational Site
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 1J8
      • Pfizer Investigational Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L 3L6
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
      • Pfizer Investigational Site
  • Nova Scotia
    • Kentville, Nova Scotia, Canada, B4N 4K9
      • Pfizer Investigational Site
    • Pictou, Nova Scotia, Canada, B0K 1H0
      • Pfizer Investigational Site
  • Ontario
    • Burlington, Ontario, Canada, L7M 4Y1
      • Pfizer Investigational Site
    • London, Ontario, Canada, N6A 4V2
      • Pfizer Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Pfizer Investigational Site
    • Toronto, Ontario, Canada, M6M 3Z5
      • Pfizer Investigational Site
  • Quebec
    • L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • Pfizer Investigational Site
    • St-Jean-sur-Richelieu, Quebec, Canada, J2W 1J1
      • Pfizer Investigational Site
    • St. Leonard, Quebec, Canada, H1S 3A9
      • Pfizer Investigational Site
• Puerto Rico
  • Cayey, Puerto Rico, 00736
    • Pfizer Investigational Site
  • Cidra, Puerto Rico, 00739
    • Pfizer Investigational Site
  • San Juan, Puerto Rico, 00907
    • Pfizer Investigational Site
  • San Juan, Puerto Rico, 00918
    • Pfizer Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Pfizer Investigational Site
    • Northport, Alabama, United States, 35476
      • Pfizer Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Pfizer Investigational Site
  • California
    • Oceanside, California, United States, 92056
      • Pfizer Investigational Site
    • San Diego, California, United States, 92123
      • Pfizer Investigational Site
    • Santa Rosa, California, United States, 95405
      • Pfizer Investigational Site
  • Colorado
    • Pueblo, Colorado, United States, 81001
      • Pfizer Investigational Site
  • Delaware
    • Hockessin, Delaware, United States, 19707
      • Pfizer Investigational Site
  • Florida
    • Bradenton, Florida, United States, 34205
      • Pfizer Investigational Site
    • Brooksville, Florida, United States, 34601
      • Pfizer Investigational Site
    • Clearwater, Florida, United States, 33756
      • Pfizer Investigational Site
    • Daytona Beach, Florida, United States, 32114
      • Pfizer Investigational Site
    • Fort Myers, Florida, United States, 33912
      • Pfizer Investigational Site
    • Fort Walton Beach, Florida, United States, 32547
      • Pfizer Investigational Site
    • Maitland, Florida, United States, 32751
      • Pfizer Investigational Site
    • Melbourne, Florida, United States, 32901
      • Pfizer Investigational Site
    • Naples, Florida, United States, 34102
      • Pfizer Investigational Site
    • Ocala, Florida, United States, 34471
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32806
      • Pfizer Investigational Site
    • Plant City, Florida, United States, 33563
      • Pfizer Investigational Site
    • Port Charlotte, Florida, United States, 33952
      • Pfizer Investigational Site
    • St. Petersburg, Florida, United States, 33709
      • Pfizer Investigational Site
    • St. Petersburg, Florida, United States, 33713
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33606
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Pfizer Investigational Site
  • Illinois
    • Burr Ridge, Illinois, United States, 60527
      • Pfizer Investigational Site
    • Elk Grove Village, Illinois, United States, 60007
      • Pfizer Investigational Site
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Pfizer Investigational Site
    • Evansville, Indiana, United States, 47714
      • Pfizer Investigational Site
    • Fort Wayne, Indiana, United States, 46805
      • Pfizer Investigational Site
    • Greenfield, Indiana, United States, 46140-2834
      • Pfizer Investigational Site
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Pfizer Investigational Site
    • Wichita, Kansas, United States, 67207
      • Pfizer Investigational Site
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
      • Pfizer Investigational Site
    • New Orleans, Louisiana, United States, 70114
      • Pfizer Investigational Site
    • Shreveport, Louisiana, United States, 71105
      • Pfizer Investigational Site
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Pfizer Investigational Site
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Pfizer Investigational Site
    • Olive Branch, Mississippi, United States, 38654
      • Pfizer Investigational Site
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Pfizer Investigational Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • Pfizer Investigational Site
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Pfizer Investigational Site
    • Oakhurst, New Jersey, United States, 07755
      • Pfizer Investigational Site
    • Toms River, New Jersey, United States, 08755
      • Pfizer Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Pfizer Investigational Site
  • New York
    • Amherst, New York, United States, 14226
      • Pfizer Investigational Site
    • Buffalo, New York, United States, 14215
      • Pfizer Investigational Site
    • Buffalo, New York, United States, 14211
      • Pfizer Investigational Site
    • Orchard Park, New York, United States, 14127
      • Pfizer Investigational Site
    • Syracuse, New York, United States, 13210
      • Pfizer Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27612
      • Pfizer Investigational Site
    • Winston Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Pfizer Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Pfizer Investigational Site
    • Fargo, North Dakota, United States, 58104
      • Pfizer Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Pfizer Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Pfizer Investigational Site
  • Oregon
    • Portland, Oregon, United States, 97210
      • Pfizer Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Pfizer Investigational Site
    • Beaver, Pennsylvania, United States, 15009
      • Pfizer Investigational Site
    • Bridgeville, Pennsylvania, United States, 15017
      • Pfizer Investigational Site
    • Grove City, Pennsylvania, United States, 16127
      • Pfizer Investigational Site
    • Indiana, Pennsylvania, United States, 15701
      • Pfizer Investigational Site
    • Norristown, Pennsylvania, United States, 19403
      • Pfizer Investigational Site
    • Scotland, Pennsylvania, United States, 17254
      • Pfizer Investigational Site
    • Upper St. Clair, Pennsylvania, United States, 15241
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Pfizer Investigational Site
    • Greer, South Carolina, United States, 29651
      • Pfizer Investigational Site
    • Murrells Inlet, South Carolina, United States, 29576
      • Pfizer Investigational Site
    • North Charleston, South Carolina, United States, 29406
      • Pfizer Investigational Site
    • Orangeburg, South Carolina, United States, 29118
      • Pfizer Investigational Site
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Pfizer Investigational Site
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Pfizer Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • Pfizer Investigational Site
  • Texas
    • Carrollton, Texas, United States, 75007
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76104
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76117
      • Pfizer Investigational Site
    • Grand Prairie, Texas, United States, 75050
      • Pfizer Investigational Site
    • Lake Jackson, Texas, United States, 77566
      • Pfizer Investigational Site
  • Virginia
    • Williamsburg, Virginia, United States, 23185
      • Pfizer Investigational Site
  • Washington
    • Kirkland, Washington, United States, 98033
      • Pfizer Investigational Site
    • Spokane, Washington, United States, 99216
      • Pfizer Investigational Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Pfizer Investigational Site
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dimebon 20 mg TID; 10 mg TID for Week 1, followed by 20 mg TID for remainder of study	Drug: Dimebon; Tablet for oral administration; Other Names: PF-01913539

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Abnormal Clinically Significant Vital Signs	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 for systolic BP; absolute diastolic BP <50 mmHg with maximum increase or decrease of >=20 mmHg from baseline and absolute heart rate values <40 beats per minute (bpm), >120 bpm for supine or sitting measurement, >140 bpm for standing measurement.	Baseline up to Week 65 (end of treatment)
Percentage of Participants With Abnormal Clinically Significant Laboratory Values	For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if observed value was more than or less than X times upper limit of normal (ULN) or lower limit of normal (LLN); X=specified in categories of each parameter in measured values section. For urinalysis abnormality was reported if result was >=1 in qualitative test of all parameters except red and white blood cells which were reported if result was >=6, indicating levels in urine were abnormal. Urine pH abnormality reported if >8 and urine specific gravity abnormality if <1.003 or >1.030.	Baseline up to Week 65 (end of treatment)
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings	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 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 >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).	Baseline up to Week 65 (end of treatment)

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Medivation, Inc.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: July 13, 2009
• First Submitted That Met QC Criteria: July 14, 2009
• First Posted (ESTIMATE): July 15, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 14, 2012
• Last Update Submitted That Met QC Criteria: October 11, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: B1451029