A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease (CONNECTION)
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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 3 |
| 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) |
- 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 ]
- 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 ]
| Enrollment: | 598 |
| Study Start Date: | May 2008 |
| Primary Completion Date: | December 2009 (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 |
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
Hide Study Locations| United States, Arizona | |
| Phoenix, Arizona, United States, 85004 | |
| United States, California | |
| Costa Mesa, California, United States | |
| Fresno, California, United States, 93720 | |
| Rancho Mirage, California, United States | |
| United States, Connecticut | |
| Hamden,, Connecticut, United States | |
| New Haven, Connecticut, United States | |
| Norwalk, Connecticut, United States | |
| 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 | |
| United States, Indiana | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Massachusetts | |
| Newton, Massachusetts, United States, 02459 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63044 | |
| United States, 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 | |
| United States, North Carolina | |
| Morganton, North Carolina, United States, 28655 | |
| United States, Ohio | |
| Centerville, Ohio, United States | |
| United States, Pennsylvania | |
| Norristown, Pennsylvania, United States | |
| United States, Texas | |
| Austin, Texas, United States | |
| United States, Wisconsin | |
| Middleton, Wisconsin, United States, 53562 | |
| Study Director: | Lynn Seely, MD | Medivation, Inc. |
More Information
No publications provided
| Responsible Party: | Medivation, Inc. |
| ClinicalTrials.gov Identifier: | NCT00675623 History of Changes |
| Other Study ID Numbers: | CONNECTION, DIM14 |
| Study First Received: | May 7, 2008 |
| Last Updated: | August 27, 2012 |
| 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 May 19, 2013