A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease - Full Text View

Sponsor:	Medivation, Inc.
Information provided by:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00675623

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 III

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia Memory

Drug Information available for: Dimebolin

U.S. FDA Resources

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 ]

Estimated Enrollment:	525
Study Start Date:	May 2008
Estimated Primary Completion Date:	July 2010 (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

Additional Information:

Click here for more information about this study: A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease (CONNECTION) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Lynn Seely, MD, Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00675623 History of Changes
Other Study ID Numbers:	CONNECTION, DIM14
Study First Received:	May 7, 2008
Last Updated:	July 14, 2009
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 February 09, 2012