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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00675623
First received: May 7, 2008
Last updated: August 27, 2012
Last verified: August 2012

May 7, 2008
August 27, 2012
May 2008
December 2009   (final data collection date for primary outcome measure)
To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the ADAS-cog; and to determine the effect of Dimebon as compared to placebo on the primary measure of global function, the CIBIC-plus. [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00675623 on ClinicalTrials.gov Archive Site
To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the ADCS-ADL; • To determine the effect of Dimebon as compared to placebo on a measure of behavior, the NPI; [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease
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)

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.

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 MMSE. Patients will attend study visits with caregivers who will provide information about the patient's condition.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
598
Not Provided
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mild-to-Moderate Alzheimer's disease
  • Probable AD (NINCDS-ADRDA and DSM-IV_
  • MMSE score 10-24 inclusive
  • CT or MRI scan consistent with AD
  • Caregiver who cares for the patient at least 5 days per week

Exclusion Criteria:

  • Anti-dementia drugs including cholinesterase-inhibitors or 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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00675623
CONNECTION, DIM14
Yes
Medivation, Inc.
Medivation, Inc.
Not Provided
Study Director: Lynn Seely, MD Medivation, Inc.
Medivation, Inc.
August 2012

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