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

Sponsor:	Pfizer
Collaborator:	Medivation, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00838110

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 III

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Dimebolin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Adverse events [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
ECG's [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Vital Signs [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Clinical Chemistry / Hematology [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00838110 History of Changes
Other Study ID Numbers:	B1451027
Study First Received:	February 5, 2009
Last Updated:	April 5, 2011
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 February 09, 2012