The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.
This study was terminated on May 7, 2010 as part of modification of the dimebon development plan following lack of demonstration of efficacy in the completed DIM14 (CONNECTION) Study. The study was not terminated due to any safety findings. Dimebon has been well -tolerated in clinical trials. Demonstration of efficacy for dimebon in Alzheimer's disease is pending completion of the ongoing DIM18 (CONCERT) Study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
649
Tablet for oral administration
Percentage of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to Week 65 (end of treatment)
Percentage of Participants With Abnormal Clinically Significant Vital Signs
Abnormal clinically significant vital signs included absolute systolic blood pressure (BP) values less than (\<) 90 millimeter of mercury (mmHg), maximum increase or decrease of greater than or equal to (\>=) 30 mmHg from baseline for systolic BP; absolute diastolic BP \<50 mmHg with maximum increase or decrease of \>=20 mmHg from baseline and absolute heart rate values \<40 beats per minute (bpm), \>120 bpm for supine or sitting measurement, \>140 bpm for standing measurement.
Time frame: Baseline up to Week 65 (end of treatment)
Percentage of Participants With Abnormal Clinically Significant Laboratory Values
For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if observed value was more than or less than X times upper limit of normal (ULN) or lower limit of normal (LLN); X=specified in categories of each parameter in measured values section. For urinalysis abnormality was reported if result was \>=1 in qualitative test of all parameters except red and white blood cells which were reported if result was \>=6, indicating levels in urine were abnormal. Urine pH abnormality reported if \>8 and urine specific gravity abnormality if \<1.003 or \>1.030.
Time frame: Baseline up to Week 65 (end of treatment)
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Abnormal ECG findings included maximum value of \>=300 millisecond (msec), maximum increase of \>=25% for baseline value of \>200 msec and maximum increase of \>=50% for baseline value of \<=200 msec for PR interval (int); maximum increase of \>=25% for baseline value of \>100 msec and maximum increase of \>=50% for baseline value of \<=100 msec for QRS interval; maximum value of \>450 to \<=480, \>480 to \<=500 and \>500 msec, increase of \>30 to \<=60 and \>60 msec for QT interval corrected using Fridericia's formula (QTcF).
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Pfizer Investigational Site
Mobile, Alabama, United States
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Northport, Alabama, United States
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Little Rock, Arkansas, United States
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Oceanside, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Pueblo, Colorado, United States
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Hockessin, Delaware, United States
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Bradenton, Florida, United States
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Brooksville, Florida, United States
...and 95 more locations
Time frame: Baseline up to Week 65 (end of treatment)