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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dimebon 20 mg TID (Cohort 1) | Experimental |
| |
| Placebo TID (Cohort 1) | Placebo Comparator |
| |
| Dimebon 20 mg TID (Cohort 2) | Experimental |
| |
| Placebo TID (Cohort 2) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimebon | Drug | 10 mg TID for week 1 followed by 20 mg TID through Week 26 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Mobile | Alabama | 36608 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dimebon (Cohort 1) | Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26. |
| FG001 | Placebo (Cohort 1) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
10 mg TID for week 1 followed by 20 mg TID through Week 26 |
|
| Dimebon | Drug | 10 mg TID for week 1 followed by 20 mg TID through Week 12 |
|
| Placebo | Drug | 20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12 |
|
| 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. | 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. | 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. | 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. | Baseline up to Week 16 (follow-up) |
| Northport |
| Alabama |
| 35476 |
| United States |
| Pfizer Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pfizer Investigational Site | Oceanside | California | 92056 | United States |
| Pfizer Investigational Site | San Diego | California | 92123 | United States |
| Pfizer Investigational Site | Santa Rosa | California | 95405 | United States |
| Pfizer Investigational Site | Pueblo | Colorado | 81001 | United States |
| Pfizer Investigational Site | Hockessin | Delaware | 19707 | United States |
| Pfizer Investigational Site | Bradenton | Florida | 34205 | United States |
| Pfizer Investigational Site | Brooksville | Florida | 34601 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33756 | United States |
| Pfizer Investigational Site | Daytona Beach | Florida | 32114 | United States |
| Pfizer Investigational Site | Daytona Beach | Florida | 32117 | United States |
| Pfizer Investigational Site | Destin | Florida | 32541 | United States |
| Pfizer Investigational Site | Fort Myers | Florida | 33912 | United States |
| Pfizer Investigational Site | Fort Walton Beach | Florida | 32547 | United States |
| Pfizer Investigational Site | Fruitland Park | Florida | 34731 | United States |
| Pfizer Investigational Site | Melbourne | Florida | 32901 | United States |
| Pfizer Investigational Site | Naples | Florida | 34102 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34471 | United States |
| Pfizer Investigational Site | Ocala | Florida | 34474 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Plant City | Florida | 33563 | United States |
| Pfizer Investigational Site | Port Charlotte | Florida | 33952 | United States |
| Pfizer Investigational Site | Port Orange | Florida | 32127 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33709 | United States |
| Pfizer Investigational Site | St. Petersburg | Florida | 33713 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33606 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33629 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30308 | United States |
| Pfizer Investigational Site | Burr Ridge | Illinois | 60527 | United States |
| Pfizer Investigational Site | Elk Grove Village | Illinois | 60007 | United States |
| Pfizer Investigational Site | Elkhart | Indiana | 46514 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47714 | United States |
| Pfizer Investigational Site | Fort Wayne | Indiana | 46805 | United States |
| Pfizer Investigational Site | Greenfield | Indiana | 46140-2834 | United States |
| Pfizer Investigational Site | Prairie Village | Kansas | 66206 | United States |
| Pfizer Investigational Site | Wichita | Kansas | 67207 | United States |
| Pfizer Investigational Site | Lake Charles | Louisiana | 70601 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71105 | United States |
| Pfizer Investigational Site | West Yarmouth | Massachusetts | 02763 | United States |
| Pfizer Investigational Site | Flowood | Mississippi | 39232 | United States |
| Pfizer Investigational Site | Olive Branch | Mississippi | 38654 | United States |
| Pfizer Investigational Site | Kansas City | Missouri | 64114 | United States |
| Pfizer Investigational Site | Springfield | Missouri | 65807 | United States |
| Pfizer Investigational Site | Great Falls | Montana | 59405 | United States |
| Pfizer Investigational Site | Eatontown | New Jersey | 07724 | United States |
| Pfizer Investigational Site | Oakhurst | New Jersey | 07755 | United States |
| Pfizer Investigational Site | Toms River | New Jersey | 08755 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pfizer Investigational Site | Amherst | New York | 14226 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14211 | United States |
| Pfizer Investigational Site | Buffalo | New York | 14215 | United States |
| Pfizer Investigational Site | Orchard Park | New York | 14127 | United States |
| Pfizer Investigational Site | Syracuse | New York | 13210 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28211 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27607 | United States |
| Pfizer Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58103 | United States |
| Pfizer Investigational Site | Fargo | North Dakota | 58104 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97210 | United States |
| Pfizer Investigational Site | Altoona | Pennsylvania | 16602 | United States |
| Pfizer Investigational Site | Beaver | Pennsylvania | 15009 | United States |
| Pfizer Investigational Site | Bridgeville | Pennsylvania | 15017 | United States |
| Pfizer Investigational Site | Grove City | Pennsylvania | 16127 | United States |
| Pfizer Investigational Site | Indiana | Pennsylvania | 15701 | United States |
| Pfizer Investigational Site | Norristown | Pennsylvania | 19401 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Pfizer Investigational Site | Scotland | Pennsylvania | 17254 | United States |
| Pfizer Investigational Site | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29425 | United States |
| Pfizer Investigational Site | Greer | South Carolina | 29651 | United States |
| Pfizer Investigational Site | Murrells Inlet | South Carolina | 29576 | United States |
| Pfizer Investigational Site | North Charleston | South Carolina | 29406-6076 | United States |
| Pfizer Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| Pfizer Investigational Site | Sioux Falls | South Dakota | 57105 | United States |
| Pfizer Investigational Site | Franklin | Tennessee | 37067 | United States |
| Pfizer Investigational Site | Knoxville | Tennessee | 37920 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Carrollton | Texas | 75007 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76104 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76117 | United States |
| Pfizer Investigational Site | Grand Prairie | Texas | 75050 | United States |
| Pfizer Investigational Site | Houston | Texas | 77074 | United States |
| Pfizer Investigational Site | Lake Jackson | Texas | 77566 | United States |
| Pfizer Investigational Site | Williamsburg | Virginia | 23185 | United States |
| Pfizer Investigational Site | Kirkland | Washington | 98033 | United States |
| Pfizer Investigational Site | Spokane | Washington | 99216 | United States |
| Pfizer Investigational Site | Charleston | West Virginia | 25304 | United States |
| Pfizer Investigational Site | La Crosse | Wisconsin | 54650 | United States |
| Pfizer Investigational Site | Calgary | Alberta | T3C 3P1 | Canada |
| Pfizer Investigational Site | Medicine Hat | Alberta | T1B 4E7 | Canada |
| Pfizer Investigational Site | Surrey | British Columbia | V4A 2H9 | Canada |
| Pfizer Investigational Site | Victoria | British Columbia | V8R 1J8 | Canada |
| Pfizer Investigational Site | Saint John | New Brunswick | E2L 3L6 | Canada |
| Pfizer Investigational Site | Bay Roberts | Newfoundland and Labrador | A0A 1G0 | Canada |
| Pfizer Investigational Site | Kentville | Nova Scotia | B4N 4K9 | Canada |
| Pfizer Investigational Site | Pictou | Nova Scotia | B0K 1H0 | Canada |
| Pfizer Investigational Site | Burlington | Ontario | L7M 4Y1 | Canada |
| Pfizer Investigational Site | Corunna | Ontario | N0N 1G0 | Canada |
| Pfizer Investigational Site | London | Ontario | N6A 4V2 | Canada |
| Pfizer Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M6M 3Z5 | Canada |
| Pfizer Investigational Site | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Pfizer Investigational Site | L'Ancienne-Lorette | Quebec | G2E 2X1 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G1J 1Z4 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G2B 5S1 | Canada |
| Pfizer Investigational Site | Saint-Jean-sur-Richelieu | Quebec | J2W 1J1 | Canada |
| Pfizer Investigational Site | Saint-Léonard | Quebec | H1S 3A9 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Pfizer Investigational Site | Cayey | PR | 00736 | Puerto Rico |
| Pfizer Investigational Site | Rio Piedras | PR | 00924 | Puerto Rico |
| Pfizer Investigational Site | San Juan | PR | 00907 | Puerto Rico |
| Pfizer Investigational Site | San Juan | PR | 00918 | Puerto Rico |
| Pfizer Investigational Site | Cidra | 00739 | Puerto Rico |
Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26. |
| FG002 | Dimebon (Cohort 2) | Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12. |
| FG003 | Placebo (Cohort 2) | Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dimebon | Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2. |
| BG001 | Placebo | Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Number | percentage of participants | Baseline up to Week 30 (follow-up) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Number | percentage of participants | Baseline up to Week 16 (follow-up) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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). | 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. | Posted | Number | percentage of participants | Baseline up to Week 30 (follow-up) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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). | 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. | Posted | Number | percentage of participants | Baseline up to Week 16 (follow-up) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Cohort 1 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively. | Posted | Number | percentage of participants | Baseline up to Week 30 (follow-up) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Cohort 2 analysis set. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular category for each group respectively. | Posted | Number | percentage of participants | Baseline up to Week 16 (follow-up) |
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Number | percentage of participants | Baseline up to Week 30 (follow-up) |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Number | percentage of participants | Baseline up to Week 16 (follow-up) |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dimebon | Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2. | 26 | 370 | 107 | 370 | ||
| EG001 | Placebo | Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2. | 28 | 371 | 110 | 371 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Sick sinus syndrome | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Uterine rupture | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| T-cell lymphoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Belligerence | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Delusion | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Bladder irritation | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C010119 | latrepirdine |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 70 to 79 years |
|
| 80 to 85 years |
|
| Greater than 85 years |
|
| Male |
|
| Decrease in systolic BP (>=30 mmHg) (n=126,124) |
|
| Diastolic BP (<50 mmHg) (n=127,127) |
|
| Increase in diastolic BP (>=20 mmHg) (n=126,124) |
|
| Decrease in diastolic BP (>=20 mmHg) (n=126,124) |
|
| Heart rate (>120 bpm) (n=127,127) |
|
| Units | Counts |
|---|
| Participants |
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