A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease
CONNECTION
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)
2 other identifiers
interventional
598
1 country
28
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 (AD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 7, 2008
CompletedFirst Posted
Study publicly available on registry
May 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedSeptember 27, 2016
September 1, 2016
1.6 years
May 7, 2008
September 24, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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).
Week 26
Secondary Outcomes (2)
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).
Week 26
To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI).
Week 26
Study Arms (3)
A
EXPERIMENTALDimebon, 5 mg orally three times daily
B
EXPERIMENTALDimebon 20 mg orally three times daily
C
PLACEBO COMPARATORPlacebo orally three times daily for six months
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivation, Inc.lead
Study Sites (28)
Unknown Facility
Phoenix, Arizona, 85004, United States
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Fresno, California, 93720, United States
Unknown Facility
Rancho Mirage, California, United States
Unknown Facility
Hamden, Connecticut, United States
Unknown Facility
New Haven, Connecticut, United States
Unknown Facility
Norwalk, Connecticut, United States
Unknown Facility
Hallandale, Florida, 33009, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Miami, Florida, 33137, United States
Unknown Facility
North Miami, Florida, 33161, United States
Unknown Facility
Sunrise, Florida, 33351, United States
Unknown Facility
West Palm Beach, Florida, 33407, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Paducah, Kentucky, 42003, United States
Unknown Facility
Newton, Massachusetts, 02459, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
St Louis, Missouri, 63044, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
Cedarhurst, New York, 11516, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, 14620, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Morganton, North Carolina, 28655, United States
Unknown Facility
Centerville, Ohio, United States
Unknown Facility
Norristown, Pennsylvania, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Middleton, Wisconsin, 53562, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lynn Seely, MD
Medivation, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2008
First Posted
May 9, 2008
Study Start
May 1, 2008
Primary Completion
December 1, 2009
Last Updated
September 27, 2016
Record last verified: 2016-09