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

Phase 3

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Dimebon

• Registration Number: NCT00939783
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of Dimebon in patients with Alzheimer's disease.

Detailed Description

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 Timeline

• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2009-09
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Disposition First Submitted: 2011-09-08
• Disposition First Submitted QC: 2011-09-08
• Disposition First Posted: 2011-09-12
• Status Verified: 2012-10
• Results First Submitted: 2012-10-11
• Results First Submitted QC: 2012-10-11
• Last Update Submitted: 2012-10-11
• Results First Posted: 2012-11-14
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 649

Inclusion Criteria

• Completion of previous Phase 3 Dimebon study (B1451027).

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Exclusion Criteria

• Have any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dimebon 20 mg TID	Dimebon	10 mg TID for Week 1, followed by 20 mg TID for remainder of study

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Baseline up to Week 65 (end of treatment)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Abnormal Clinically Significant Vital Signs	Baseline up to Week 65 (end of treatment)	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 With Abnormal Clinically Significant Laboratory Values	Baseline up to Week 65 (end of treatment)	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 With Clinically Significant Electrocardiogram (ECG) Findings	Baseline up to Week 65 (end of treatment)	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).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 San Juan, Puerto Rico