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

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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).

Time frame: 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.