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
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: Dimebon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 598
Study Start Date: May 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Dimebon, 5 mg orally three times daily
Drug: Dimebon
Dimebon, 5 mg orally three times daily for six months
Experimental: B
Dimebon 20 mg orally three times daily
Drug: Dimebon
Dimebon 20 mg orally three times daily for six months
Placebo Comparator: C
Placebo orally three times daily for six months
Drug: Placebo
Placebo three times daily for six months

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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00675623

  Show 28 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Investigators
Study Director: Lynn Seely, MD Medivation, Inc.
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00675623     History of Changes
Other Study ID Numbers: CONNECTION, DIM14
Study First Received: May 7, 2008
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Alzheimer's disease, clinical trial, memory loss, mitochondria,
investigational drug, neurodegenerative disease, dementia

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 April 15, 2014