A Phase 3 Study To Evaluate The Safety And Tolerability Of Dimebon Patients With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00838110
First received: February 5, 2009
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.


Condition Intervention Phase
Alzheimer's Disease
Drug: Dimebon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind Placebo-Controlled Study To Evaluate The Safety And Tolerability Of Dimebon (PF-01913539) For Up To 26-Weeks In Patients With Mild To Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 1 [ Time Frame: Baseline up to Week 30 (follow-up) ] [ Designated as safety issue: Yes ]
    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; absolute diastolic BP value: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 beats per minute (bpm).

  • Percentage of Participants With Abnormal Clinically Significant Vital Signs in Cohort 2 [ Time Frame: Baseline up to Week 16 (follow-up) ] [ Designated as safety issue: Yes ]
    Abnormal clinically significant vital signs included absolute systolic BP values: <90 mmHg, maximum increase or decrease of >=30 mmHg from baseline; absolute diastolic BP values: <50 mmHg, maximum increase or decrease of >=20 mmHg from baseline; absolute heart rate values: >120 bpm.

  • Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 1 [ Time Frame: Baseline up to Week 30 (follow-up) ] [ Designated as safety issue: Yes ]
    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 value of >=200 msec, 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 >=500 msec for QT 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 interval).

  • Percentage of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings in Cohort 2 [ Time Frame: Baseline up to Week 16 (follow-up) ] [ Designated as safety issue: Yes ]
    Abnormal ECG findings included maximum value of >=300 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; maximum value of >=200 msec, 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 >=500 msec for QT 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 interval).

  • Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 1 [ Time Frame: Baseline up to Week 30 (follow-up) ] [ Designated as safety issue: Yes ]
    For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the upper limit of normal (ULN) or lower limit of normal (LLN) respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.

  • Percentage of Participants With Abnormal Clinically Significant Laboratory Values in Cohort 2 [ Time Frame: Baseline up to Week 16 (follow-up) ] [ Designated as safety issue: Yes ]
    For hematology, liver function, renal function, electrolytes, clinical chemistry, abnormality was reported if the observed value was more than or less than X times the ULN or LLN respectively; X=specified in categories of each parameter in the measured values section. For urinalysis of glucose, ketones, protein, blood, abnormality was reported if result was >=1 in qualitative test of respective parameters, indicating levels in urine were abnormal. Urine pH and specific gravity abnormality reported if pH >8 and specific gravity <1.003 or >1.030.

  • Percentage of Participants With Adverse Events (AEs) in Cohort 1 [ Time Frame: Baseline up to Week 30 (follow-up) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  • Percentage of Participants With Adverse Events (AEs) in Cohort 2 [ Time Frame: Baseline up to Week 16 (follow-up) ] [ Designated as safety issue: Yes ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.


Enrollment: 742
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dimebon 20 mg TID (Cohort 1) Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 26
Placebo Comparator: Placebo TID (Cohort 1) Drug: Placebo
10 mg TID for week 1 followed by 20 mg TID through Week 26
Experimental: Dimebon 20 mg TID (Cohort 2) Drug: Dimebon
10 mg TID for week 1 followed by 20 mg TID through Week 12
Placebo Comparator: Placebo TID (Cohort 2) Drug: Placebo
20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's Disease.
  • MMSE 12-26 inclusive.
  • If on existing anti-dementia therapy, have been on a stable dose of anti-dementia therapy (cholinesterase inhibitors and/or memantine) for at least 60 days prior to dosing in study.
  • If not taking existing anti-dementia therapy, have not received therapy with cholinesterase inhibitors and/or memantine within 60 days prior to dosing in this study.

Exclusion Criteria:

  • Have major structural brain disease (e.g., ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [e.g., thalamus, hippocampus]).
  • Have any major medical illness or unstable medical condition within six months of screening that may interfere with the patient's ability to comply with study procedures and abide by study restrictions.
  • Have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing or intend to start anti-dementia therapy during the double blind portion of the study.
  • Reside in a nursing home or assisted care facility with need for 24-hour care and supervision.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838110

  Show 119 Study Locations
Sponsors and Collaborators
Pfizer
Medivation, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00838110     History of Changes
Other Study ID Numbers: B1451027
Study First Received: February 5, 2009
Results First Received: October 11, 2012
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Alzheimer's Disease
Dimebon
Safety
Tolerability

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014