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

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NCT00675623

Last updated on November 17, 2019
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Study Location
Phoenix, Arizona, 85004 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00675623
Pfizer
Completed
A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease

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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 SummaryThe 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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: August 27, 2012)		598
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2008)		525
Study Completion Date  ICMJE Not Provided
Actual Primary Completion DateDecember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00675623
Other Study ID Numbers  ICMJE CONNECTION
DIM14
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyMedivation, Inc.
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Lynn Seely, MDMedivation, Inc.
PRS AccountMedivation, Inc.
Verification DateSeptember 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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