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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 7, 2008

Last Updated Date

August 27, 2012

Start Date ^ICMJE

May 2008

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00675623 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Enrollment ^ICMJE

598

Completion Date

Not Provided

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 (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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00675623

Other Study ID Numbers ^ICMJE

CONNECTION, DIM14

Has Data Monitoring Committee

Yes

Responsible Party

Medivation, Inc.

Study Sponsor ^ICMJE

Medivation, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Lynn Seely, MD

Medivation, Inc.

Information Provided By

Medivation, Inc.

Verification Date

August 2012

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

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