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A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease (CONNECTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00675623
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE May 9, 2008
Last Update Posted Date September 27, 2016
Study Start Date  ICMJE May 2008
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2016)
  • To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). [ Time Frame: Week 26 ]
  • To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus). [ Time Frame: Week 26 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 8, 2008)
To determine the benefit of Dimebon as compared to placebo on the primary measure of cognition and memory, the ADAS-cog; and to determine the benefit of Dimebon as compared to placebo on the primary measure of global function, the CIBIC-plus. [ Time Frame: Week 26 ]
Change History Complete list of historical versions of study NCT00675623 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2016)
  • To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL). [ Time Frame: Week 26 ]
  • To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI). [ Time Frame: Week 26 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2008)
To determine the benefit of Dimebon as compared to placebo on a measure of self care and daily function, the ADCS-ADL; • To determine the benefit of Dimebon as compared to placebo on a measure of behavior, the NPI; [ Time Frame: Week 26 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease
Official Title  ICMJE A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)
Brief Summary The Connection Study is a six-month confirmatory Phase 3 study to determine the safety and efficacy of Dimebon in the treatment of mild-to-moderate Alzheimer's disease (AD).
Detailed Description

This study is a randomized, placebo-controlled 6-month study designed as an adequate and well-controlled trial to demonstrate the safety and efficacy of Dimebon in the treatment of patients with mild-to-moderate AD. Dimebon is an investigational drug for Alzheimer's disease. The target of Dimebon's mechanism of action are the mitochondria (a cell's primary source of energy).The Connection Study is the second of two pivotal studies evaluating the effect of Dimebon. It is a 6-month study enrolling 525 patients in the United States, Europe, and South America. All patients completing the 6-month study will be eligible to receive Dimebon in an open-label extension trial.

The patient population will be carefully selected to ensure inclusion of patients with AD, rather than other types of dementia. Mild-to-moderate disease will be defined by the screening Mini-Mental State Examination (MMSE). Patients will attend study visits with caregivers who will provide information about the patient's condition.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Dimebon
    Dimebon, 5 mg orally three times daily for six months
  • Drug: Dimebon
    Dimebon 20 mg orally three times daily for six months
  • Drug: Placebo
    Placebo three times daily for six months
Study Arms  ICMJE
  • Experimental: A
    Dimebon, 5 mg orally three times daily
    Intervention: Drug: Dimebon
  • Experimental: B
    Dimebon 20 mg orally three times daily
    Intervention: Drug: Dimebon
  • Placebo Comparator: C
    Placebo orally three times daily for six months
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2012)
598
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2008)
525
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Mild-to-Moderate Alzheimer's disease
  • Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
  • MMSE score 10-24 inclusive
  • Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD
  • Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

  • Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days
  • Other causes of dementia
  • Other primary psychiatric or neurological disorders
  • Unstable medical illnesses or significant hepatic or renal disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00675623
Other Study ID Numbers  ICMJE CONNECTION
DIM14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medivation, Inc.
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lynn Seely, MD Medivation, Inc.
PRS Account Medivation, Inc.
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP