Alzheimer DiseasePhase 3NCT00912288
A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease
A Phase 3 study testing Dimebon 20 mg po TID in people with Alzheimer Disease, run by Pfizer at 47 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Dimebon 20 mg po TID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 47 sitesin 8 countries
- Study dates
- Sep 2009to Aug 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
47 sites in 8 countries.
47 sites in 8 countries
United States21 sites
Pfizer Investigational Site
Brooksville, Florida, 34601
Pfizer Investigational Site
Cordova, Tennessee, 38018
Pfizer Investigational Site
Costa Mesa, California, 92626
Pfizer Investigational Site
Delray Beach, Florida, 33445
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
East Providence, Rhode Island, 02914
Pfizer Investigational Site
Encino, California, 91316
Pfizer Investigational Site
Indianapolis, Indiana, 46260
Pfizer Investigational Site
Lexington, Kentucky, 40503
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Middleton, Wisconsin, 53562
Pfizer Investigational Site
New Haven, Connecticut, 06510
Pfizer Investigational Site
Newport Beach, California, 92660-2452
Pfizer Investigational Site
Newport Beach, California, 92663
Pfizer Investigational Site
Norristown, Pennsylvania, 19401
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Pittsfield, Massachusetts, 01201
Pfizer Investigational Site
Princeton, New Jersey, 08540
Pfizer Investigational Site
Rochester, New York, 14620
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
West Palm Beach, Florida, 33407
Germany6 sites
Pfizer Investigational Site
Berlin, 13581
Pfizer Investigational Site
Bochum, 44892
Pfizer Investigational Site
Günzburg, 89312
Pfizer Investigational Site
Leipzig, 04107
Pfizer Investigational Site
Mainz, 55131
Pfizer Investigational Site
Mittweida, 09648
Spain5 sites
Pfizer Investigational Site
Algorta, Getxo, Bilbao, 48993
Pfizer Investigational Site
Barcelona, Barcelona, 08014
Pfizer Investigational Site
Barcelona, Barcelona, 08041
Pfizer Investigational Site
Salt, Girona, 17190
Pfizer Investigational Site
Seville, Sevilla, 41071
Slovakia4 sites
Pfizer Investigational Site
Bratislava, 82007
Pfizer Investigational Site
Michalovce, 071 01
Pfizer Investigational Site
Rožňava, 04801
Pfizer Investigational Site
Žilina, 01001
Canada3 sites
Pfizer Investigational Site
Montreal, Quebec, H4H-1R3
Pfizer Investigational Site
Québec, Quebec, G2B 5S1
Pfizer Investigational Site
Winnipeg, Manitoba, R3M 0X9
Hungary3 sites
Pfizer Investigational Site
Budapest, 1083
Pfizer Investigational Site
Gyula, 5700
Pfizer Investigational Site
Székesfehérvár, 8000
Turkey (Türkiye)3 sites
Pfizer Investigational Site
Istanbul, 34390
Pfizer Investigational Site
Kocaeli, 41400
Pfizer Investigational Site
Samsun, 55139
Portugal2 sites
Pfizer Investigational Site
Amadora, 2700-276
Pfizer Investigational Site
Coimbra, 3000-548
About this study
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
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Dimebon 20 mg po TID, Placebo po TID
- Keywords
- Alzheimer disease moderate-to-severe memantine safety and efficacy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimebon 20 mg po TIDDrug
Also called PF-01913539, Latrepirdine Dihydrochloride
Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks
Placebo po TIDDrug
Placebo (matched to Dimebon) po for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dimebon | Experimental | Not described Receives: Drug: Dimebon 20 mg po TID |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo po TID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Severe Impairment Battery (SIB) Score at 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.
Measured: Baseline, Week 26
Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (Severe) (ADCS-ADLsev) Score at 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.
Measured: Baseline, Week 26
Secondary outcomes (8)
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at 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.
Measured: Baseline, Week 26
Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI
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.
Measured: Week 26
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 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.
Measured: Baseline, Week 26
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores
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.
Measured: Week 26
Resource Utilization in Dementia-Lite Version (RUD-Lite)
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.
Measured: Baseline, Weeks 12, 18, 26
Euro Quality of Life - 5 Domain (EQ-5D) Assessment
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.
Measured: Baseline, Weeks 12, 26
Population Pharmacokinetic (PK) Analysis
Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov 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.
Measured: Pre-dose, 0.5 to 1.5 hours, 2.5 to 3.5 hours post-dose at Week 12
Number of Participants With Adverse Events (AEs)
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.
Measured: Baseline up to Week 30 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912288
- Sponsor's protocol ID
- B1451006
- Status last verified
- Aug 2012
- First submitted
- 1 Jun 2009
- Last updated
- 2 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00912288
- Acronym / sponsor ID
- B1451006
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer disease moderate-to-severe memantine safety and efficacy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Medivation, Inc.
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 2 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dimebon | Experimental | Drug: Dimebon 20 mg po TID |
| Placebo | Placebo comparator | Drug: Placebo po TID |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimebon 20 mg po TIDAlso: PF-01913539, Latrepirdine DihydrochlorideDimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks | Drug | Dimebon |
| Placebo po TIDPlacebo (matched to Dimebon) po for 26 weeks | Drug | Placebo |
Primary outcome
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.
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.
8 secondary outcomes
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 26
Time frame: Baseline, Week 26
Sum of the Delusions and Hallucinations Sub-domain Scores of the NPI
Time frame: Week 26
Change From Baseline in the Mini-Mental State Examination (MMSE) Score at Week 26
Time frame: Baseline, Week 26
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Scores
Time frame: Week 26
Resource Utilization in Dementia-Lite Version (RUD-Lite)
Time frame: Baseline, Weeks 12, 18, 26
Euro Quality of Life - 5 Domain (EQ-5D) Assessment
Time frame: Baseline, Weeks 12, 26
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
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Week 30 (follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
47 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dimebon 20 mg po TID in people with Alzheimer Disease, run by Pfizer at 47 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Germany, Spain, Slovakia, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Severe Impairment Battery (SIB) Score at Week 26 (time frame: Baseline, Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.