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

September 24, 2016 updated by: Medivation, Inc.

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 (AD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

598

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
    • California
      • Costa Mesa, California, United States
      • Fresno, California, United States, 93720
      • Rancho Mirage, California, United States
    • Connecticut
      • Hamden,, Connecticut, United States
      • New Haven, Connecticut, United States
      • Norwalk, Connecticut, United States
    • Florida
      • Hallandale Beach, Florida, United States, 33009
      • Hialeah, Florida, United States
      • Miami, Florida, United States, 33137
      • North Miami, Florida, United States, 33161
      • Sunrise, Florida, United States, 33351
      • West Palm Beach, Florida, United States, 33407
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kentucky
      • Paducah, Kentucky, United States, 42003
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
    • Michigan
      • Ann Arbor, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States, 63044
    • New York
      • Brooklyn, New York, United States
      • Cedarhurst, New York, United States, 11516
      • New York City, New York, United States
      • Rochester, New York, United States, 14620
      • Staten Island, New York, United States
    • North Carolina
      • Morganton, North Carolina, United States, 28655
    • Ohio
      • Centerville, Ohio, United States
    • Pennsylvania
      • Norristown, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Dimebon, 5 mg orally three times daily
Drug: Dimebon
Dimebon, 5 mg orally three times daily for six months
Drug: Dimebon
Dimebon 20 mg orally three times daily for six months
EXPERIMENTAL: B
Dimebon 20 mg orally three times daily
Drug: Dimebon
Dimebon, 5 mg orally three times daily for six months
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medivation, Inc.

Investigators

  • Study Director: Lynn Seely, MD, Medivation, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 8, 2008

First Posted (ESTIMATE)

May 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CONNECTION
  • DIM14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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