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

A Phase 3 study testing Dimebon in people with Alzheimer's Disease, run by Pfizer at 105 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 50 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: Dimebon
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 649 participants
Where: 105 sitesin 3 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

Completion of previous Phase 3 Dimebon study (B1451027).

Who cannot join

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.

Trial locations and contacts

105 sites in 3 countries.

Country

City, postcode or hospital

105 sites in 3 countries

United States84 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87109
Pfizer Investigational Site
Altoona, Pennsylvania, 16602
Pfizer Investigational Site
Amherst, New York, 14226
Pfizer Investigational Site
Atlanta, Georgia, 30308
Pfizer Investigational Site
Beaver, Pennsylvania, 15009
Pfizer Investigational Site
Bradenton, Florida, 34205
Pfizer Investigational Site
Bridgeville, Pennsylvania, 15017
Pfizer Investigational Site
Brooksville, Florida, 34601
Pfizer Investigational Site
Buffalo, New York, 14211
Pfizer Investigational Site
Buffalo, New York, 14215
Pfizer Investigational Site
Burr Ridge, Illinois, 60527
Pfizer Investigational Site
Carrollton, Texas, 75007
Pfizer Investigational Site
Charleston, South Carolina, 29425
Pfizer Investigational Site
Charleston, West Virginia, 25304
Pfizer Investigational Site
Charlotte, North Carolina, 28211
Pfizer Investigational Site
Cincinnati, Ohio, 45227
Pfizer Investigational Site
Clearwater, Florida, 33756
Pfizer Investigational Site
Daytona Beach, Florida, 32114
Pfizer Investigational Site
Eatontown, New Jersey, 07724
Pfizer Investigational Site
Elk Grove Village, Illinois, 60007
Pfizer Investigational Site
Elkhart, Indiana, 46514
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Fargo, North Dakota, 58104
Pfizer Investigational Site
Flowood, Mississippi, 39232
Pfizer Investigational Site
Fort Myers, Florida, 33912
Pfizer Investigational Site
Fort Walton Beach, Florida, 32547
Pfizer Investigational Site
Fort Wayne, Indiana, 46805
Pfizer Investigational Site
Fort Worth, Texas, 76104
Pfizer Investigational Site
Fort Worth, Texas, 76117
Pfizer Investigational Site
Franklin, Tennessee, 37067
Pfizer Investigational Site
Grand Prairie, Texas, 75050
Pfizer Investigational Site
Great Falls, Montana, 59405
Pfizer Investigational Site
Greenfield, Indiana, 46140-2834
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Grove City, Pennsylvania, 16127
Pfizer Investigational Site
Hockessin, Delaware, 19707
Pfizer Investigational Site
Hyannis, Massachusetts, 02601
Pfizer Investigational Site
Indiana, Pennsylvania, 15701
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
La Crosse, Wisconsin, 54601
Pfizer Investigational Site
Lake Charles, Louisiana, 70601
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Maitland, Florida, 32751
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Murrells Inlet, South Carolina, 29576
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
New Orleans, Louisiana, 70114
Pfizer Investigational Site
Norristown, Pennsylvania, 19403
Pfizer Investigational Site
North Charleston, South Carolina, 29406
Pfizer Investigational Site
Northport, Alabama, 35476
Pfizer Investigational Site
Oakhurst, New Jersey, 07755
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Oceanside, California, 92056
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73112
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Orangeburg, South Carolina, 29118
Pfizer Investigational Site
Orchard Park, New York, 14127
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Plant City, Florida, 33563
Pfizer Investigational Site
Port Charlotte, Florida, 33952
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Prairie Village, Kansas, 66206
Pfizer Investigational Site
Pueblo, Colorado, 81001
Pfizer Investigational Site
Raleigh, North Carolina, 27612
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Santa Rosa, California, 95405
Pfizer Investigational Site
Scotland, Pennsylvania, 17254
Pfizer Investigational Site
Shreveport, Louisiana, 71105
Pfizer Investigational Site
Sioux Falls, South Dakota, 57105
Pfizer Investigational Site
Spokane, Washington, 99216
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
St. Petersburg, Florida, 33713
Pfizer Investigational Site
Syracuse, New York, 13210
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Toms River, New Jersey, 08755
Pfizer Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Pfizer Investigational Site
Wichita, Kansas, 67207
Pfizer Investigational Site
Williamsburg, Virginia, 23185
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Canada17 sites

Pfizer Investigational Site
Bay Roberts, Newfoundland and Labrador, A0A 1G0
Pfizer Investigational Site
Burlington, Ontario, L7M 4Y1
Pfizer Investigational Site
Calgary, Alberta, T3C 3P1
Pfizer Investigational Site
Kentville, Nova Scotia, B4N 4K9
Pfizer Investigational Site
L'Ancienne-Lorette, Quebec, G2E 2X1
Pfizer Investigational Site
London, Ontario, N6A 4V2
Pfizer Investigational Site
Medicine Hat, Alberta, T1B 4E7
Pfizer Investigational Site
Pictou, Nova Scotia, B0K 1H0
Pfizer Investigational Site
Québec, Quebec, G1J 1Z4
Pfizer Investigational Site
Québec, Quebec, G2B 5S1
Pfizer Investigational Site
Saint John, New Brunswick, E2L 3L6
Pfizer Investigational Site
Saint-Jean-sur-Richelieu, Quebec, J2W 1J1
Pfizer Investigational Site
Saint-Léonard, Quebec, H1S 3A9
Pfizer Investigational Site
Sarnia, Ontario, N7T 4X3
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
Toronto, Ontario, M6M 3Z5
Pfizer Investigational Site
Victoria, British Columbia, V8R 1J8

Other trials in Canada

Puerto Rico4 sites

Pfizer Investigational Site
Cayey, 00736
Pfizer Investigational Site
Cidra, 00739
Pfizer Investigational Site
San Juan, 00907
Pfizer Investigational Site
San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Conditions: Alzheimer's Disease
Being tested: Dimebon
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DimebonDrug
Also called PF-01913539
Tablet for oral administration

Study groups in NCT00939783
Study group	Role	What they receive
Dimebon 20 mg TID	Experimental	10 mg TID for Week 1, followed by 20 mg TID for remainder of study Receives: Drug: Dimebon

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline up to Week 65 (end of treatment)

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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).
Measured: Baseline up to Week 65 (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009Aug 2010

First posted15 Jul 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's 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 649 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00939783
Sponsor's protocol ID: B1451029
Status last verified: Oct 2012
First submitted: 13 Jul 2009
Last updated: 14 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease

All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00939783
Acronym / sponsor ID: B1451029
Conditions: Alzheimer's Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 649 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: 15 Jul 2009 (estimated)
Results: Posted 14 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dimebon 20 mg TID	Experimental	Drug: Dimebon10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Completion of previous Phase 3 Dimebon study (B1451027).

Key exclusion criteria (1 listed)

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.

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
DimebonAlso: PF-01913539Tablet for oral administration	Drug	Dimebon 20 mg TID

Primary outcome

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.

3 secondary outcomes

Percentage of Participants With Abnormal Clinically Significant Vital Signs
Time frame: 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)
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Baseline up to Week 65 (end of treatment)

Results and safety

Results posted to the registry on 14 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dimebon	649	0

Primary outcome: Percentage of Participants With Adverse Events (AEs)

Time frame: Baseline up to Week 65 (end of treatment). Number. Unit: Percentage of participants

Measure	Dimebon n = 648
Value	73.1

Population analysed: Safety analysis set included all the participants who received at least one dose of study medication, including partial doses.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dimebon	76 of 648 (11.7%)	313 of 648 (48.3%)	Not reported

Limitations and caveats (from the sponsor): This safety study did not specify primary or secondary outcome measures. Relevant summaries of all safety assessments are thus provided. Urine blood abnormalities seen are deemed due to interference with dipstick test by a metabolite of dimebon.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 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.

Related trials for Alzheimer's Disease

Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease

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

105 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dimebon in people with Alzheimer's Disease, run by Pfizer at 105 sites in 3 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 1 inclusion and 1 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 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Canada, Puerto Rico. 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. 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 14 Nov 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?

Percentage of Participants With Adverse Events (AEs) (time frame: Baseline up to Week 65 (end of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00939783.

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 14 Nov 2012.