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

October 11, 2012 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
649

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs)
Time Frame: Baseline up to Week 65 (end of treatment)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Time Frame: Baseline up to Week 65 (end of treatment)
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
Time Frame: Baseline up to Week 65 (end of treatment)
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
Time Frame: Baseline up to Week 65 (end of treatment)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medivation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B1451029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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