A Phase 3 Efficacy Study Of Dimebon In Patients With Moderate To Severe Alzheimer's Disease - Full Text View

Sponsor:	Pfizer
Collaborator:	Medivation, Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00912288

Purpose

No Dimebon clinical data exist yet in patients with disease that has advanced to the moderate-to-severe stage. Therefore, this study evaluates the safety and efficacy of Dimebon in patients with moderate-to-severe AD who are receiving existing background therapy with memantine.

Condition	Intervention	Phase
Alzheimer Disease	Drug: Dimebon 20 mg po TID Drug: Placebo po TID	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy 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 26-Week Trial To Evaluate The Efficacy And Safety Of Dimebon In Patients With Moderate-To-Severe Alzheimer's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Dimebolin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline in the Severe Impairment Battery [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from Baseline in ADCS-Activities of Daily Living (severe) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the Neuropsychiatric Inventory [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from baseline in the Clinician's Global Impression of Change (plus caregiver input) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from baseline in Mini-mental State Exam [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from baseline Resource Utilization in Dementia [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from baseline in EuroQoL - 5 Domain assessment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Safety and Tolerability including adverse events and summary of clinically important changes in clinical safety laboratory assessments, electrocardiograms, and vital signs [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	576
Study Start Date:	September 2009
Estimated Study Completion Date:	November 2011
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dimebon: Experimental	Drug: Dimebon 20 mg po TID Dimebon 10 mg po TID for 1 week followed by Dimebon 20 mg TID for 25 weeks
Placebo: Placebo Comparator	Drug: Placebo po TID Placebo (matched to Dimebon) po for 26 weeks

Detailed Description:

This study was terminated on May 7, 2010 due to modification of the dimebon development plan following the 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.

Eligibility

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

Criteria

Inclusion Criteria:

Are men and women ≥ 50 years of age with a diagnosis of Alzheimers disease.
Have a Mini-Mental State Exam between 5 and 14 inclusive.
Have been taking the medication memantine (ie., Namenda) for at least six months prior to this study.
Must have a caregiver who assists the patient at least five days per week for at least three hours per day, who can accompany patient to study visits, and who has an intimate knowledge of the patient's health states and personal care.

Exclusion Criteria:

Have taken medicines for Alzheimers disease other than memantine (e.g., donepezil, rivastigmine, galantamine, tacrine) within 2 months prior to this study.
Dementia other than Alzheimers disease.
Any medical condition or reason that interferes with the ability of the patient to participate in or complete the trial or places the patient at undue risk, as judged by the study doctor.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912288

Show 47 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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
ClinicalTrials.gov Identifier:	NCT00912288 History of Changes
Other Study ID Numbers:	B1451006
Study First Received:	June 1, 2009
Last Updated:	August 17, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Alzheimer disease moderate-to-severe memantine safety and efficacy

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 September 01, 2010