A Phase 3 interventional study of Dimebon in Alzheimer's Disease, sponsored by Pfizer. Terminated at 106 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-11-14.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 649 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 mg TID for Week 1, followed by 20 mg TID for remainder of study
Drug: Dimebon
Tablet for oral administration
Also known as: PF-01913539
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).
Time frame: Baseline up to Week 65 (end of treatment)
| Milestone | Dimebon |
|---|---|
| Started | 649 |
| Treated | 648 |
| Completed | 0 |
| Not completed | 649 |
| Withdrew: Death | 6 |
| Withdrew: Adverse event | 39 |
| Withdrew: Study terminated by sponsor | 498 |
| Withdrew: Withdrawal by subject | 78 |
| Withdrew: Other | 16 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Enrolled but not treated | 1 |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
| Percentage of participants | Dimebon |
|---|---|
| Percentage of Participants With Adverse Events (AEs) | 73.1 |
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 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.
| Percentage of participants | Dimebon |
|---|---|
| Systolic BP (<90 mmHg) (n=646) | 1.1 |
| Increase in systolic BP (>=30 mmHg) (n=642) | 11.5 |
| Decrease in systolic BP (>=30 mmHg) (n=642) | 12.0 |
| Diastolic BP (<50 mmHg) (n=646) | 2.0 |
| Increase in diastolic BP (>=20 mmHg) (n=642) | 8.1 |
| Decrease in diastolic BP (>=20 mmHg) (n=642) | 9.7 |
| Heart rate (<40 bpm) (n=646) | 0.0 |
| Heart rate (>120/>140 bpm) (n=646) | 0.0 |
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.
| Percentage of participants | Dimebon |
|---|---|
| Hemoglobin (<0.8*LLN) (n=646) | 0.3 |
| Red blood cell count (< 0.8*LLN) (n=646) | 0.5 |
| Mean corpuscular volume (<0.9*LLN) (n=646) | 0.8 |
| Mean corpuscular volume (>1.1*ULN) (n=646) | 0.2 |
| Platelets (>1.75*ULN) (n=646) | 0.2 |
| White blood cell count (<0.6*LLN) (n=646) | 0.2 |
| White blood cell count (>1.5*ULN) (n=646) | 0.2 |
| Lymphocytes (<0.8*LLN) (n=646) | 1.4 |
| Lymphocytes (>1.2*ULN) (n=646) | 2.6 |
| Total neutrophils (<0.8*LLN) (n=646) | 0.6 |
| Total neutrophils (>1.2*ULN) (n=646) | 4.3 |
| Eosinophils (>1.2*ULN) (n=646) | 1.4 |
| Monocytes (>1.2*ULN) (n=646) | 1.5 |
| Total bilirubin(>1.5*ULN) (n=646) | 0.3 |
| Aspartate aminotransferase (>3.0*ULN) (n=645) | 0.5 |
| Alanine aminotransferase (>3.0*ULN) (n=645) | 0.9 |
| Alkaline phosphatase (>3.0*ULN) (n=646) | 0.2 |
| Albumin (>1.2*ULN) (n=646) | 0.2 |
| Blood urea nitrogen (>1.3*ULN) (n=646) | 1.4 |
| Creatinine (>1.3*ULN) (n=646) | 1.4 |
| Sodium (<0.95*LLN) (n=646) | 0.3 |
| Sodium (>1.05*ULN) (n=646) | 0.9 |
| Potassium (<0.9*LLN) (n=645) | 0.6 |
| Potassium (>1.1*ULN) (n=645) | 0.5 |
| Calcium (>1.1*ULN) (n=646) | 0.3 |
| Magnesium (<0.9*LLN) (n=646) | 0.5 |
| Magnesium (>1.1*ULN) (n=646) | 22.0 |
| Phosphate (<0.8*LLN) (n=646) | 0.2 |
| Phosphate (>1.2*ULN) (n=646) | 0.2 |
| Bicarbonate (<0.9*LLN) (n=646) | 0.8 |
| Bicarbonate (>1.1*ULN) (n=646) | 0.2 |
| Glucose (>1.5*ULN) (n=646) | 17.6 |
| Creatine kinase (>2.0*ULN) (n=646) | 2.5 |
| Urine specific gravity (>1.030) (n=643) | 3.4 |
| Urine pH (>8) (n=643) | 0.3 |
| Urine glucose (>=1) (n=643) | 5.3 |
| Urine ketones (>=1) (n=643) | 2.2 |
| Urine protein (>=1) (n=643) | 3.3 |
| Urine blood (>=1) (n=643) | 52.1 |
| Urine leukocyte esterase (>=1) (n=643) | 29.4 |
| Urine RBC (>=6) (n=518) | 18.1 |
| Urine WBC (>=6) (n=562) | 34.3 |
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).
| Percentage of participants | Dimebon |
|---|---|
| PR int (>=300 msec) (n=608) | 0.3 |
| Increase in PR int (>=25/50%) (n=605) | 0.3 |
| Increase in QRS int (>=25/50%) (n=646) | 1.4 |
| QTcF int (>450 to <=480 msec) (n=646) | 18.3 |
| QTcF int (>480 to <=500 msec) (n=646) | 1.9 |
| QTcF int (>500 msec) (n=646) | 0.3 |
| Increase in QTcF int (>30 to <=60 msec) (n=646) | 8.0 |
| Increase in QTcF int (>60 msec) (n=646) | 0.3 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dimebon | — | 76/648 (11.7%) | 313/648 (48.3%) |
| Event | Dimebon |
|---|---|
| Chest painGeneral disorders | 6/648 |
| Urinary tract infectionInfections and infestations | 6/648 |
| Hip fractureInjury, poisoning and procedural complications | 6/648 |
| PneumoniaInfections and infestations | 3/648 |
| SepsisInfections and infestations | 3/648 |
| FallInjury, poisoning and procedural complications | 3/648 |
| Femur fractureInjury, poisoning and procedural complications | 3/648 |
| DeliriumPsychiatric disorders | 3/648 |
| Mental status changesPsychiatric disorders | 3/648 |
| BradycardiaCardiac disorders | 2/648 |
| Event | Dimebon |
|---|---|
| Urinary tract infectionInfections and infestations | 73/648 |
| FallInjury, poisoning and procedural complications | 59/648 |
| SomnolenceNervous system disorders | 43/648 |
| DiarrhoeaGastrointestinal disorders | 28/648 |
| FatigueGeneral disorders | 28/648 |
| HeadacheNervous system disorders | 25/648 |
| Confusional statePsychiatric disorders | 23/648 |
| Oedema peripheralGeneral disorders | 22/648 |
| ContusionInjury, poisoning and procedural complications | 22/648 |
| DizzinessNervous system disorders | 20/648 |
| Age, Customized(Participants) | Dimebon |
|---|---|
| 50 to 59 years | 32 |
| 60 to 69 years | 100 |
| 70 to 79 years | 269 |
| 80 to 85 years | 187 |
| Greater than 85 years | 60 |
| Sex: Female, Male(Participants) | Dimebon |
|---|---|
| Female | 342 |
| Male | 306 |
Showing the first 100 of 106 sites across 3 countries.
This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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