Skip to main content
OpenTrials
Completed

NCT Number: NCT00829374

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Newcastle, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dimebon

Drug

5 mg orally three times daily

placebo comparator

Drug

Placebo orally three times daily

Primary outcomes

  1. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    Time frame: Week 52

  2. Alzheimer's Disease Assessment Scale - Cognitive Subscale

    Time frame: Week 52

Secondary outcomes

  1. Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)

    Time frame: Week 52

  2. Neuropsychiatric Inventory (NPI)

    Time frame: Week 52

  3. Resource Utilization in Dementia Lite (RUD lite)

    Time frame: Week 52

  4. Euro Quality of Life 5 (EQ-5D)

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

Medivation, Inc.

Industry

Collaborators

  • Pfizer

Registry information

Official study 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

Acronym: CONCERT

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2009
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.