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A Phase 3 Efficacy Study Of Dimebon In Patients 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: NCT00912288
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 3, 2009
Results First Posted : October 2, 2012
Last Update Posted : October 2, 2012
Medivation, Inc.
Information provided by (Responsible Party):

Brief Summary:
No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Dimebon 20 mg po TID Drug: Placebo po TID 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 26-Week Trial To Evaluate The Efficacy And Safety Of Dimebon In Patients With Moderate-To-Severe Alzheimer's Disease
Study Start Date : September 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dimebon Drug: Dimebon 20 mg po TID
Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks
Other Names:
  • PF-01913539
  • Latrepirdine Dihydrochloride

Placebo Comparator: Placebo Drug: Placebo po TID
Placebo (matched to Dimebon) po for 26 weeks

Primary Outcome Measures :
  1. Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26 [ Time Frame: Baseline, Week 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 the Alzheimer's Disease Cooperative Study - Activities of Daily Living (Severe) (ADCS-ADLsev) Score at Week 26 [ Time Frame: Baseline, Week 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.

Secondary Outcome Measures :
  1. Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26 [ Time Frame: Baseline, Week 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.

  2. Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI [ 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.

  3. Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26 [ Time Frame: Baseline, Week 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; total ranged from 0 to 30, higher score indicates better cognitive state.

  4. Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores [ Time Frame: Week 26 ]
    Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) version of CIBIC-Plus was used to assess participant's overall disease severity. The corresponding baseline assessment rated participant on 7-point scale: (1) extremely severe AD to (7) no symptoms of AD. Overall impression of change from baseline was rated on a 7-point scale: 1=marked improvement; 2=moderate improvement; 3=minimal improvement; 4=no change; 5=minimal worsening; 6=moderate worsening; 7=marked worsening; all assessments are relative to baseline. Higher score = worsening of global function.

  5. Resource Utilization in Dementia-Lite Version (RUD-Lite) [ Time Frame: Baseline, Weeks 12, 18, 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 resources utilized.

  6. Euro Quality of Life - 5 Domain (EQ-5D) Assessment [ Time Frame: Baseline, Weeks 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. Total possible score ranged from 5 to 15; lower score indicated a better health state.

  7. Population Pharmacokinetic (PK) Analysis [ Time Frame: Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12 ]
    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  8. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 30 (follow-up) ]
    Any untoward medical occurrence (including clinially important changes in clinical safety laboratory assessments, electrocardiograms and vital signs) in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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:

  • Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.
  • Have a Mini-Mental State Exam between 5 and 14 inclusive.
  • Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.
  • Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.

Exclusion Criteria:

  • Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.
  • Dementia other than Alzheimers disease.
  • Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.

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): NCT00912288

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United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
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
Pfizer Investigational Site
Newport Beach, California, United States, 92663
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80218
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
United States, Florida
Pfizer Investigational Site
Brooksville, Florida, United States, 34601
Pfizer Investigational Site
Delray Beach, Florida, United States, 33445
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40503
United States, Massachusetts
Pfizer Investigational Site
Pittsfield, Massachusetts, United States, 01201
United States, New Jersey
Pfizer Investigational Site
Princeton, New Jersey, United States, 08540
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14620
Pfizer Investigational Site
Syracuse, New York, United States, 13210
United States, Pennsylvania
Pfizer Investigational Site
Norristown, Pennsylvania, United States, 19401
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
United States, Tennessee
Pfizer Investigational Site
Cordova, Tennessee, United States, 38018
United States, Wisconsin
Pfizer Investigational Site
Middleton, Wisconsin, United States, 53562
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3M 0X9
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H4H-1R3
Pfizer Investigational Site
Quebec, Canada, G2B 5S1
Pfizer Investigational Site
Berlin, Germany, 13581
Pfizer Investigational Site
Bochum, Germany, 44892
Pfizer Investigational Site
Guenzburg, Germany, 89312
Pfizer Investigational Site
Leipzig, Germany, 04107
Pfizer Investigational Site
Mainz, Germany, 55131
Pfizer Investigational Site
Mittweida, Germany, 09648
Pfizer Investigational Site
Budapest, Hungary, 1083
Pfizer Investigational Site
Gyula, Hungary, 5700
Pfizer Investigational Site
Szekesfehervar, Hungary, 8000
Pfizer Investigational Site
Amadora, Portugal, 2700-276
Pfizer Investigational Site
Coimbra, Portugal, 3000-548
Pfizer Investigational Site
Bratislava, Slovakia, 82007
Pfizer Investigational Site
Michalovce, Slovakia, 071 01
Pfizer Investigational Site
Roznava, Slovakia, 04801
Pfizer Investigational Site
Zilina, Slovakia, 01001
Pfizer Investigational Site
Algorta, Getxo, Bilbao, Spain, 48993
Pfizer Investigational Site
Salt, Girona, Spain, 17190
Pfizer Investigational Site
Barcelona, Spain, 08014
Pfizer Investigational Site
Barcelona, Spain, 08041
Pfizer Investigational Site
Sevilla, Spain, 41071
Pfizer Investigational Site
Istanbul, Turkey, 34390
Pfizer Investigational Site
Kocaeli, Turkey, 41400
Pfizer Investigational Site
Samsun, Turkey, 55139
Sponsors and Collaborators
Medivation, Inc.
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT00912288    
Other Study ID Numbers: B1451006
First Posted: June 3, 2009    Key Record Dates
Results First Posted: October 2, 2012
Last Update Posted: October 2, 2012
Last Verified: August 2012
Keywords provided by Pfizer:
Alzheimer disease moderate-to-severe memantine safety and efficacy
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders