An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066546
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : February 10, 2010
Results First Posted : October 2, 2012
Last Update Posted : October 2, 2012
Medivation, Inc.
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the long-term safety and tolerability of dimebon in subjects with moderate-to-severe Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Dimebon tablet for oral administration Phase 3

Detailed Description:
This study was terminated on May 7, 2010 due to modification of the dimebon development plan, following the 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  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension To The B1451006 Protocol To Evaluate The Safety And Efficacy Of Dimebon (Latrepirdine, PF-01913539) In Subjects With Moderate-To-Severe Alzheimer's Disease
Study Start Date : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dimebon Drug: Dimebon tablet for oral administration
10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to 4 weeks after last dose of study treatment ]
    An adverse event is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Secondary Outcome Measures :
  1. Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26 [ Time Frame: Baseline, Week 6, 12, 26 ]
    SIB developed for evaluation of cognitive function in participants, who demented to a degree that they cannot complete conventional neuropsychological testing. Test items consisted of simple, one-step commands presented with gestural cues and instructions that were repeated if necessary. SIB test consisted of 51-item scale, divided into 9 subscales: social interaction (0-6), memory (0-14), orientation (0-6), language (0-46), attention (0-6), praxis (0-8), visuospatial ability (0-8), construction(0-4), orienting to name(0-2). Total possible score:0-100; lower score=greater cognitive impairment.

  2. Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26 [ Time Frame: Baseline, Week 6, 12, 26 ]
    ADCS-ADLsev: 19-item scale measures basic and instrumental abilities in participant population and had good metric properties and reliability in detecting change. Individual score range: 0 to 5 for telephone, 0 to 4 for dressing, watch television, get around outside home, 0 to 3 for eating, walking, toilet, bathing, grooming, conversation/small talk, clear dishes, find personal belongings, obtain beverages, dispose of garbage, left on own, 0 to 1 for run water from and turn off faucet to wash hands, turn on and off light. Total score range: 0 to 54 lower scores=greater functional impairment.

  3. Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26 [ Time Frame: Baseline, Week 12, 26 ]
    MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; ranged from 0 to 30, higher score indicates better cognitive state.

  4. Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26 [ Time Frame: Baseline, Week 6, 12, 26 ]
    NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity(1=Mild to 3=Severe),frequency(1=occasionally to 4=very frequently) scales recorded for each domain; frequency*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances;negative change score from baseline=improvement.

  5. Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26 [ Time Frame: Week 26 ]
    NPI is a 12-domain caregiver assessment of behavioral disturbances occurring in dementia. Severity (1=Mild to 3=Severe) and frequency (1=occasionally to 4=very frequently) scales were recorded separately for each domain and their product gives individual domain score (range 0-12). Sum of delusions and hallucinations sub-domain scores of NPI was calculated as a measure of Alzheimer's Disease (AD) related psychosis. Total possible score range: 0-24 with higher score indicating greater behavioral disturbances.

  6. Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26 [ Time Frame: Baseline, Week 12, 26 ]
    RUD Lite: instrument used to assess amount of both formal and informal resources used by demented participants and primary caregiver. It was completed by caregivers and compiles data on following resources: use of social services, frequency and duration of hospitalizations, all contacts with health care professionals, participant living accommodations, amount of time the caregiver spends giving care and the impact of care giving on the caregiver's job. Overall cost of care was evaluated to quantify the resources utilized.

  7. Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16 [ Time Frame: Baseline, Week 12, 26 ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Total possible score is sum of individual items, ranged from 5 to 15; lower score indicated a better health state.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon study

Exclusion Criteria:

  • Any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066546

United States, California
Pfizer Investigational Site
Costa Mesa, California, United States, 92626
Pfizer Investigational Site
Encino, California, United States, 91316
Pfizer Investigational Site
Los Alamitos, California, United States, 90720
Pfizer Investigational Site
Newport Beach, California, United States, 92660-2452
United States, Florida
Pfizer Investigational Site
Delray Beach, Florida, United States, 33445
Sponsors and Collaborators
Medivation, Inc.
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01066546     History of Changes
Other Study ID Numbers: B1451030
First Posted: February 10, 2010    Key Record Dates
Results First Posted: October 2, 2012
Last Update Posted: October 2, 2012
Last Verified: August 2012

Keywords provided by Pfizer:
Cognitive Disorders
Mental Disorders
Nervous System Diseases
Central Nervous System Diseases

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders