Alzheimer's DiseasePhase 3NCT00838110

A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

A Phase 3 study testing Dimebon in people with Alzheimer's Disease, run by Pfizer at 118 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Alzheimer's Disease
What is being tested?: Dimebon
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 742 participants
Where: 118 sitesin 3 countries
Study dates: Feb 2009to Jan 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

Diagnosis of Alzheimer's Disease.
MMSE 12-26 inclusive.
If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Who cannot join

Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.

Trial locations and contacts

118 sites in 3 countries.

Country

City, postcode or hospital

118 sites in 3 countries

United States93 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
Daytona Beach, Florida, 32117
Pfizer Investigational Site
Destin, Florida, 32541
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
Fruitland Park, Florida, 34731
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
Houston, Texas, 77074
Pfizer Investigational Site
Indiana, Pennsylvania, 15701
Pfizer Investigational Site
Kansas City, Missouri, 64114
Pfizer Investigational Site
Kirkland, Washington, 98033
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
La Crosse, Wisconsin, 54650
Pfizer Investigational Site
Lake Charles, Louisiana, 70601
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Little Rock, Arkansas, 72205
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
Nashville, Tennessee, 37203
Pfizer Investigational Site
Norristown, Pennsylvania, 19401
Pfizer Investigational Site
North Charleston, South Carolina, 29406-6076
Pfizer Investigational Site
Northport, Alabama, 35476
Pfizer Investigational Site
Oakhurst, New Jersey, 07755
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
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
Pittsburgh, Pennsylvania, 15241
Pfizer Investigational Site
Plant City, Florida, 33563
Pfizer Investigational Site
Port Charlotte, Florida, 33952
Pfizer Investigational Site
Port Orange, Florida, 32127
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, 27607
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
Tampa, Florida, 33629
Pfizer Investigational Site
Toms River, New Jersey, 08755
Pfizer Investigational Site
Upper Saint Clair, Pennsylvania, 15241
Pfizer Investigational Site
West Yarmouth, Massachusetts, 02763
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

Canada20 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
Corunna, Ontario, N0N 1G0
Pfizer Investigational Site
Greenfield Park, Quebec, J4V 2J2
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
Surrey, British Columbia, V4A 2H9
Pfizer Investigational Site
Toronto, Ontario, M6M 3Z5
Pfizer Investigational Site
Victoria, British Columbia, V8R 1J8

Other trials in Canada

Puerto Rico5 sites

Pfizer Investigational Site
Cayey, PR, 00736
Pfizer Investigational Site
Cidra, 00739
Pfizer Investigational Site
Rio Piedras, PR, 00924
Pfizer Investigational Site
San Juan, PR, 00907
Pfizer Investigational Site
San Juan, PR, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease

This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.

Conditions: Alzheimer's Disease
Being tested: Dimebon, Placebo
Keywords: Alzheimer's Disease, Dimebon, Safety, Tolerability
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
10 mg TID for week 1 followed by 20 mg TID through Week 26
PlaceboDrug
10 mg TID for week 1 followed by 20 mg TID through Week 26
DimebonDrug
10 mg TID for week 1 followed by 20 mg TID through Week 12
PlaceboDrug
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

Study groups in NCT00838110
Study group	Role	What they receive
Dimebon 20 mg TID (Cohort 1)	Experimental	Not described Receives: Drug: Dimebon
Placebo TID (Cohort 1)	Placebo comparator	Not described Receives: Drug: Placebo
Dimebon 20 mg TID (Cohort 2)	Experimental	Not described Receives: Drug: Dimebon
Placebo TID (Cohort 2)	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
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; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).
Measured: Baseline up to Week 30 (follow-up)
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.
Measured: Baseline up to Week 16 (follow-up)
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
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 value of >=200 msec, 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 >=500 msec for QT 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 interval).
Measured: Baseline up to Week 30 (follow-up)
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
Abnormal ECG findings included maximum value of >=300 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; maximum value of >=200 msec, 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 >=500 msec for QT 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 interval).
Measured: Baseline up to Week 16 (follow-up)
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.
Measured: Baseline up to Week 30 (follow-up)
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.
Measured: Baseline up to Week 16 (follow-up)
Percentage of Participants With Adverse Events (AEs) in Cohort 1
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 30 (follow-up)
Percentage of Participants With Adverse Events (AEs) in Cohort 2
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 16 (follow-up)

Timeline

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

Feb 2009Jan 2010

First posted6 Feb 2009 (estimated)
Study startFeb 2009
Primary completionJan 2010
Study completionJan 2010

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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 742 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00838110
Sponsor's protocol ID: B1451027
Status last verified: Nov 2018
First submitted: 5 Feb 2009
Last updated: 6 Dec 2018
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?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2018. 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 Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT00838110
Acronym / sponsor ID: B1451027
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease, Dimebon, Safety, Tolerability
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 742 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Medivation, Inc.
Study start: Feb 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 6 Feb 2009 (estimated)
Results: Posted 8 Feb 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
Dimebon 20 mg TID (Cohort 1)	Experimental	Drug: Dimebon
Placebo TID (Cohort 1)	Placebo comparator	Drug: Placebo
Dimebon 20 mg TID (Cohort 2)	Experimental	Drug: Dimebon
Placebo TID (Cohort 2)	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of Alzheimer's Disease.
MMSE 12-26 inclusive.
If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Key exclusion criteria (4 listed)

Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.

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
Dimebon10 mg TID for week 1 followed by 20 mg TID through Week 26	Drug	Dimebon 20 mg TID (Cohort 1)
Placebo10 mg TID for week 1 followed by 20 mg TID through Week 26	Drug	Placebo TID (Cohort 1)
Dimebon10 mg TID for week 1 followed by 20 mg TID through Week 12	Drug	Dimebon 20 mg TID (Cohort 2)
Placebo20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12	Drug	Placebo TID (Cohort 2)

Primary outcome

Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1
Time frame: Baseline up to Week 30 (follow-up)
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; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).
Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2
Time frame: Baseline up to Week 16 (follow-up)
Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1
Time frame: Baseline up to Week 30 (follow-up)
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 value of >=200 msec, 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 >=500 msec for QT 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 interval).
Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2
Time frame: Baseline up to Week 16 (follow-up)
Abnormal ECG findings included maximum value of >=300 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; maximum value of >=200 msec, 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 >=500 msec for QT 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 interval).
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1
Time frame: Baseline up to Week 30 (follow-up)
For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.
Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2
Time frame: Baseline up to Week 16 (follow-up)
For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.
Percentage of Participants With Adverse Events (AEs) in Cohort 1
Time frame: Baseline up to Week 30 (follow-up)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Percentage of Participants With Adverse Events (AEs) in Cohort 2
Time frame: Baseline up to Week 16 (follow-up)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Results and safety

Results posted to the registry on 8 Feb 2013, 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 (Cohort 1)	127	105
Placebo (Cohort 1)	128	106
Dimebon (Cohort 2)	243	226
Placebo (Cohort 2)	244	226

Primary outcome: Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1

Time frame: Baseline up to Week 30 (follow-up). Number. Unit: percentage of participants

Measure	Dimebon (Cohort 1) n = 127	Placebo (Cohort 1) n = 127
Systolic BP (<90 mmHg) (n=127,127)	0.8	1.6
Increase in systolic BP (>=30 mmHg) (n=126,124)	9.5	10.5
Decrease in systolic BP (>=30 mmHg) (n=126,124)	16.7	12.9
Diastolic BP (<50 mmHg) (n=127,127)	0.8	1.6
Increase in diastolic BP (>=20 mmHg) (n=126,124)	7.1	7.3
Decrease in diastolic BP (>=20 mmHg) (n=126,124)	15.9	12.9
Heart rate (>120 bpm) (n=127,127)	0.0	0.0

Population analysed: Cohort 1 analysis set included all those participants in the safety analysis set (SAS) (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.

Primary outcome: Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2

Time frame: Baseline up to Week 16 (follow-up). Number. Unit: percentage of participants

Measure	Dimebon (Cohort 2) n = 243	Placebo (Cohort 2) n = 244
Systolic BP (<90 mmHg) (n=243,244)	0.8	0.0
Increase in systolic BP (>=30 mmHg) (n=240,240)	3.8	8.3
Decrease in systolic BP (>=30 mmHg) (n=240,240)	9.6	8.8
Diastolic BP (<50 mmHg) (n=243,244)	1.2	0.8
Increase in diastolic BP (>=20 mmHg) (n=240,240)	6.3	5.4
Decrease in diastolic BP (>=20 mmHg) (n=240,240)	6.7	7.5
Heart rate (>120 bpm) (n=243,244)	0.0	0.0

Population analysed: Cohort 2 analysis set included all those participants in the SAS (all participants who receive at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.

Primary outcome: Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1

Time frame: Baseline up to Week 30 (follow-up). Number. Unit: percentage of participants

Measure	Dimebon (Cohort 1) n = 127	Placebo (Cohort 1) n = 127
PR int (>=300 msec) (n=123,113)	0.0	0.0
Increase in PR int (>=25/50%) (n=122,112)	0.0	0.0
QRS int (>=200 msec) (n=127,127)	0.0	0.0
Increase in QRS int (>=25/50%) (n=126,126)	1.6	0.0
QT int (>=500 msec) (n=127,127)	0.0	2.4
QTcF int (450 to <480 msec) (n=127,127)	15.7	13.4
QTcF int (480 to <500 msec) (n=127,127)	1.6	4.7
QTcF int (>=500 msec) (n=127,127)	0.0	0.8

Population analysed: Cohort 1 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 1 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.

Primary outcome: Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2

Time frame: Baseline up to Week 16 (follow-up). Number. Unit: percentage of participants

Measure	Dimebon (Cohort 2) n = 243	Placebo (Cohort 2) n = 244
PR int (>=300 msec) (n=232,232)	0.9	0.0
Increase in PR int (>=25/50%) (n=231,229)	0.0	0.0
QRS int (>=200 msec) (n=243,244)	0.0	0.0
Increase in QRS int (>=25/50%) (n=242,243)	0.8	0.4
QT int (>=500 msec) (n=243,244)	0.8	0.8
QTcF int (450 to <480 msec) (n=243,244)	15.6	19.3
QTcF int (480 to <500 msec) (n=243,244)	2.1	0.8
QTcF int (>=500 msec) (n=243,244)	1.2	0.0

Population analysed: Cohort 2 analysis set included all those participants in the SAS (all participants who received at least one dose of study medication, including partial doses) who were randomized into cohort 2 of the study. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dimebon	26 of 370 (7%)	107 of 370 (28.9%)	Not reported
Placebo	28 of 371 (7.5%)	110 of 371 (29.6%)	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 6 Dec 2018.
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

118 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 118 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 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. 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 8 Feb 2013). 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 Abnormal Clinically Significant Vital Signs in Cohort 1 (time frame: Baseline up to Week 30 (follow-up)). The study lists 8 primary outcomes in all. 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 NCT00838110.

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 6 Dec 2018.