Safety and Cognitive Function Study of EVP-6124 in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT01073228
Last Updated: 2014-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
409 participants
INTERVENTIONAL
2010-04-30
2012-02-29
Brief Summary
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Detailed Description
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Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EVP-6124 0.3 mg
one 0.3 mg capsule every day for 183 days
EVP-6124
EVP-6124 1 mg
one 1 mg capsule every day for 183 days
EVP-6124
EVP-6124 2 mg
one 2 mg capsule every day for 183 days
EVP-6124
Placebo
Placebo every day for 183 days
Placebo
Interventions
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EVP-6124
Placebo
Eligibility Criteria
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Inclusion Criteria
* Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment
* Modified Hachinski Ischemic Score (mHIS) ≤4 at screening
* Female subjects are ≥1 year post-menopausal or are surgically sterile
* Caregiver available; if not living in the same household, caregiver sees subject at least four times each week
* Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care
* General health status acceptable for participation in a 24 week clinical trial be administered
Exclusion Criteria
* Participation in another therapeutic clinical trial within 30 days before Baseline
* Prior participation in an amyloid vaccination clinical study
* Inability to swallow capsules
* Likely inability to complete 24 week study
* Inability to be ≥75% compliant with single-blind placebo run-in medication
* Inability to adequately perform cognitive tests
* History of significant cardiovascular disease
* Major depression
* Psychosis
* History of stroke within 18 months of screening
* Head trauma
* Inability to perform any screening or baseline evaluations
50 Years
85 Years
ALL
No
Sponsors
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INC Research Limited
INDUSTRY
FORUM Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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HOPE Research Institute
Phoenix, Arizona, United States
Catalina Research Institute
Chino, California, United States
ATP Clinical Research
Costa Mesa, California, United States
University of California, Irvine
Orange, California, United States
Radiant Research
Santa Rosa, California, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Meridien Research
Brooksville, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
MD Clinical
Hallandale, Florida, United States
Galiz Research
Miami Springs, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Memory Enhancement Center of NJ
Toms River, New Jersey, United States
Brooklyn Medical Institute
Brooklyn, New York, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Advanced Bio Behavioral Sciences Inc.
Elmsford, New York, United States
University of Rochester Medical Center at MCH
Rochester, New York, United States
Columbus Research and Wellness Institute
Columbus, Ohio, United States
Summit Research Network
Portland, Oregon, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
The Memory Clinic
Bennington, Vermont, United States
The Center for Excellence in Aging and Geriatric Health
Williamsburg, Virginia, United States
Clinical Site 1
Bucharest, , Romania
Clinical Site 2
Bucharest, , Romania
Clinical Site 3
Bucharest, , Romania
Clinical Site 4
Bucharest, , Romania
Clinical Site 5
Bucharest, , Romania
Iași, , Romania
Oradea, , Romania
Târgu Mureş, , Romania
Kazan', , Russia
Clinical Site 1
Moscow, , Russia
Clinical Site 2
Moscow, , Russia
Clinical Site 1
Saint Petersburg, , Russia
Clinical Site 2
Saint Petersburg, , Russia
Clinical Site 3
Saint Petersburg, , Russia
Clinical Site 4
Saint Petersburg, , Russia
Saratov, , Russia
Voronezh, , Russia
Yekaterinburg, , Russia
Clinical site 1
Belgrade, , Serbia
Clinical Site 2
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Dnipro, , Ukraine
Donets'k, , Ukraine
(1)
Kyiv, , Ukraine
(2)
Kyiv, , Ukraine
Odesa, , Ukraine
Simferopol, , Ukraine
Vinnytsia, , Ukraine
Countries
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Other Identifiers
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EVP-6124-010
Identifier Type: -
Identifier Source: org_study_id
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