Trial Outcomes & Findings for An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease (NCT NCT00939783)
NCT ID: NCT00939783
Last Updated: 2012-11-14
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
649 participants
Primary outcome timeframe
Baseline up to Week 65 (end of treatment)
Results posted on
2012-11-14
Participant Flow
Participant milestones
| Measure |
Dimebon
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Overall Study
STARTED
|
649
|
|
Overall Study
Treated
|
648
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
649
|
Reasons for withdrawal
| Measure |
Dimebon
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Overall Study
Death
|
6
|
|
Overall Study
Adverse Event
|
39
|
|
Overall Study
Study Terminated by Sponsor
|
498
|
|
Overall Study
Withdrawal by Subject
|
78
|
|
Overall Study
Other
|
16
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Enrolled but not treated
|
1
|
Baseline Characteristics
An Extension To The B1451027 Protocol To Evaluate The Long Term Safety And Tolerability Of Dimebon In Patients With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Dimebon
n=648 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Age, Customized
50 to 59 years
|
32 Participants
n=93 Participants
|
|
Age, Customized
60 to 69 years
|
100 Participants
n=93 Participants
|
|
Age, Customized
70 to 79 years
|
269 Participants
n=93 Participants
|
|
Age, Customized
80 to 85 years
|
187 Participants
n=93 Participants
|
|
Age, Customized
Greater than 85 years
|
60 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
342 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
306 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 65 (end of treatment)Population: Safety analysis set included all the participants who received at least one dose of study medication, including partial doses.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Dimebon
n=648 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs)
|
73.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 65 (end of treatment)Population: Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.
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.
Outcome measures
| Measure |
Dimebon
n=646 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Systolic BP (<90 mmHg) (n=646)
|
1.1 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Increase in systolic BP (>=30 mmHg) (n=642)
|
11.5 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Decrease in systolic BP (>=30 mmHg) (n=642)
|
12.0 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Diastolic BP (<50 mmHg) (n=646)
|
2.0 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Increase in diastolic BP (>=20 mmHg) (n=642)
|
8.1 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Decrease in diastolic BP (>=20 mmHg) (n=642)
|
9.7 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Heart rate (<40 bpm) (n=646)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Heart rate (>120/>140 bpm) (n=646)
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 65 (end of treatment)Population: Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular laboratory parameter.
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.
Outcome measures
| Measure |
Dimebon
n=646 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
White blood cell count (>1.5*ULN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine pH (>8) (n=643)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine glucose (>=1) (n=643)
|
5.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine ketones (>=1) (n=643)
|
2.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine protein (>=1) (n=643)
|
3.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine blood (>=1) (n=643)
|
52.1 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine leukocyte esterase (>=1) (n=643)
|
29.4 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine RBC (>=6) (n=518)
|
18.1 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine WBC (>=6) (n=562)
|
34.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Hemoglobin (<0.8*LLN) (n=646)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Red blood cell count (< 0.8*LLN) (n=646)
|
0.5 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Mean corpuscular volume (<0.9*LLN) (n=646)
|
0.8 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Mean corpuscular volume (>1.1*ULN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Platelets (>1.75*ULN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
White blood cell count (<0.6*LLN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Lymphocytes (<0.8*LLN) (n=646)
|
1.4 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Lymphocytes (>1.2*ULN) (n=646)
|
2.6 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Total neutrophils (<0.8*LLN) (n=646)
|
0.6 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Total neutrophils (>1.2*ULN) (n=646)
|
4.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Eosinophils (>1.2*ULN) (n=646)
|
1.4 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Monocytes (>1.2*ULN) (n=646)
|
1.5 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Total bilirubin(>1.5*ULN) (n=646)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Aspartate aminotransferase (>3.0*ULN) (n=645)
|
0.5 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Alanine aminotransferase (>3.0*ULN) (n=645)
|
0.9 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Alkaline phosphatase (>3.0*ULN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Albumin (>1.2*ULN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Blood urea nitrogen (>1.3*ULN) (n=646)
|
1.4 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Creatinine (>1.3*ULN) (n=646)
|
1.4 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Sodium (<0.95*LLN) (n=646)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Sodium (>1.05*ULN) (n=646)
|
0.9 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Potassium (<0.9*LLN) (n=645)
|
0.6 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Potassium (>1.1*ULN) (n=645)
|
0.5 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Calcium (>1.1*ULN) (n=646)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Magnesium (<0.9*LLN) (n=646)
|
0.5 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Magnesium (>1.1*ULN) (n=646)
|
22.0 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Phosphate (<0.8*LLN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Phosphate (>1.2*ULN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Bicarbonate (<0.9*LLN) (n=646)
|
0.8 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Bicarbonate (>1.1*ULN) (n=646)
|
0.2 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Glucose (>1.5*ULN) (n=646)
|
17.6 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Creatine kinase (>2.0*ULN) (n=646)
|
2.5 Percentage of participants
|
|
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
Urine specific gravity (>1.030) (n=643)
|
3.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 65 (end of treatment)Population: Safety analysis set included all the participants who received at least one dose of study medication, including partial doses. Here 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure and 'n' is signifying those participants who were evaluable for a particular category.
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).
Outcome measures
| Measure |
Dimebon
n=646 Participants
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Increase in QTcF int (>30 to <=60 msec) (n=646)
|
8.0 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Increase in QTcF int (>60 msec) (n=646)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
PR int (>=300 msec) (n=608)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Increase in PR int (>=25/50%) (n=605)
|
0.3 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Increase in QRS int (>=25/50%) (n=646)
|
1.4 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
QTcF int (>450 to <=480 msec) (n=646)
|
18.3 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
QTcF int (>480 to <=500 msec) (n=646)
|
1.9 Percentage of participants
|
|
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
QTcF int (>500 msec) (n=646)
|
0.3 Percentage of participants
|
Adverse Events
Dimebon
Serious events: 76 serious events
Other events: 313 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dimebon
n=648 participants at risk
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
0.15%
1/648
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.
|
|
Cardiac disorders
Atrial flutter
|
0.15%
1/648
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.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.15%
1/648
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.
|
|
Cardiac disorders
Bradycardia
|
0.31%
2/648
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.
|
|
Cardiac disorders
Cardiac arrest
|
0.31%
2/648
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
2/648
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.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.15%
1/648
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.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.15%
1/648
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.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.15%
1/648
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.
|
|
Gastrointestinal disorders
Volvulus
|
0.15%
1/648
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.
|
|
General disorders
Chest discomfort
|
0.31%
2/648
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.
|
|
General disorders
Chest pain
|
0.93%
6/648
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.
|
|
General disorders
Pyrexia
|
0.15%
1/648
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.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.15%
1/648
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.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.15%
1/648
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.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.15%
1/648
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.15%
1/648
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.
|
|
Hepatobiliary disorders
Jaundice
|
0.15%
1/648
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.
|
|
Immune system disorders
Hypersensitivity
|
0.15%
1/648
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.
|
|
Infections and infestations
Appendicitis perforated
|
0.15%
1/648
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.
|
|
Infections and infestations
Bronchitis
|
0.31%
2/648
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.
|
|
Infections and infestations
Cellulitis
|
0.31%
2/648
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.
|
|
Infections and infestations
Clostridial infection
|
0.15%
1/648
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.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.15%
1/648
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.
|
|
Infections and infestations
Device related infection
|
0.15%
1/648
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.
|
|
Infections and infestations
Herpes zoster
|
0.15%
1/648
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.
|
|
Infections and infestations
Pneumonia
|
0.46%
3/648
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.
|
|
Infections and infestations
Sepsis
|
0.46%
3/648
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.
|
|
Infections and infestations
Urinary tract infection
|
0.93%
6/648
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.
|
|
Injury, poisoning and procedural complications
Facial bones fractures
|
0.15%
1/648
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.
|
|
Injury, poisoning and procedural complications
Fall
|
0.46%
3/648
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.46%
3/648
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.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.15%
1/648
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.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.93%
6/648
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.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.15%
1/648
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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.15%
1/648
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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.15%
1/648
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.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.15%
1/648
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.
|
|
Injury, poisoning and procedural complications
Uterine rupture
|
0.15%
1/648
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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
1/648
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.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.15%
1/648
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.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.31%
2/648
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.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.15%
1/648
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.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.15%
1/648
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
1/648
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.15%
1/648
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.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.15%
1/648
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.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
2/648
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.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.15%
1/648
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.
|
|
Nervous system disorders
Grand mal convulsion
|
0.15%
1/648
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.
|
|
Nervous system disorders
Mental impairment
|
0.31%
2/648
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.
|
|
Nervous system disorders
Presyncope
|
0.15%
1/648
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.
|
|
Nervous system disorders
Syncope
|
0.31%
2/648
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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.31%
2/648
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.
|
|
Psychiatric disorders
Acute psychosis
|
0.15%
1/648
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.
|
|
Psychiatric disorders
Agitation
|
0.15%
1/648
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.
|
|
Psychiatric disorders
Delirium
|
0.46%
3/648
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.
|
|
Psychiatric disorders
Mental status changes
|
0.46%
3/648
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.
|
|
Psychiatric disorders
Psychotic disorder
|
0.15%
1/648
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
1/648
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.
|
|
Renal and urinary disorders
Renal failure acute
|
0.15%
1/648
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.
|
|
Renal and urinary disorders
Urinary retention
|
0.31%
2/648
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.
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.15%
1/648
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
2/648
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.15%
1/648
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
1/648
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
1/648
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.
|
|
Vascular disorders
Deep vein thrombosis
|
0.31%
2/648
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.
|
|
Vascular disorders
Haemodynamic instability
|
0.15%
1/648
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.
|
Other adverse events
| Measure |
Dimebon
n=648 participants at risk
Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
2.6%
17/648
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
28/648
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.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
15/648
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.
|
|
General disorders
Fatigue
|
4.3%
28/648
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.
|
|
General disorders
Oedema peripheral
|
3.4%
22/648
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.
|
|
Infections and infestations
Bronchitis
|
2.0%
13/648
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
14/648
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.
|
|
Infections and infestations
Urinary tract infection
|
11.3%
73/648
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.4%
22/648
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.
|
|
Injury, poisoning and procedural complications
Fall
|
9.1%
59/648
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.
|
|
Investigations
Weight increased
|
2.0%
13/648
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.
|
|
Musculoskeletal and connective tissue disorders
Anthralgia
|
2.5%
16/648
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
15/648
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.
|
|
Nervous system disorders
Dizziness
|
3.1%
20/648
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.
|
|
Nervous system disorders
Headache
|
3.9%
25/648
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.
|
|
Nervous system disorders
Memory impairment
|
2.3%
15/648
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.
|
|
Nervous system disorders
Somnolence
|
6.6%
43/648
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.
|
|
Psychiatric disorders
Agitation
|
3.1%
20/648
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.
|
|
Psychiatric disorders
Anxiety
|
2.9%
19/648
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.
|
|
Psychiatric disorders
Confusional state
|
3.5%
23/648
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.
|
|
Psychiatric disorders
Depression
|
2.8%
18/648
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.
|
|
Psychiatric disorders
Insomnia
|
2.3%
15/648
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.
|
|
Vascular disorders
Hypertension
|
2.8%
18/648
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER