Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

Alzheimer's Disease Clinical Trial

— CONCERT  

Official title:

CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829374
• Other study ID #: DIM18
• Status: Completed
• Phase: Phase 3
• First received: January 23, 2009
• Last updated: September 24, 2016
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2016
• Source: Medivation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Mild-to-moderate Alzheimer's disease (AD)

• Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))

• Mini-Mental State Examination (MMSE) score between 12 and 24, inclusive

• Stable on donepezil for at least 6 months

Exclusion Criteria:

• Other causes of dementia

• Major structural brain disease

• Unstable medical condition or significant hepatic or renal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Dimebon
5 mg orally three times daily
• Dimebon
20 mg orally three times daily
• Placebo comparator
Placebo orally three times daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medivation, Inc.	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Finland,  France,  Germany,  Italy,  New Zealand,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)		Week 52	No
Primary	Alzheimer's Disease Assessment Scale - Cognitive Subscale		Week 52	No
Secondary	Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)		Week 52	No
Secondary	Neuropsychiatric Inventory (NPI)		Week 52	No
Secondary	Resource Utilization in Dementia Lite (RUD lite)		Week 52	No
Secondary	Euro Quality of Life 5 (EQ-5D)		Week 52	No