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Sponsors and Collaborators: |
Corcept Therapeutics Institute for the Study of Aging (ISOA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00105105 |
The purpose of this study is to evaluate the effects of C-1073 (Mifepristone) on cognition in patients with Alzheimer’s disease (AD) who are also taking an acetylcholinesterase inhibitor (Aricept, Exelon or Reminyl).
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Mifepristone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of C-1073 (Mifepristone) as Adjunctive Therapy in Alzheimer's Disease |
Estimated Enrollment: | 160 |
Study Start Date: | April 2003 |
Estimated Study Completion Date: | April 2006 |
This will be a double blind, placebo controlled study of C-1073 to evaluate the effects on cognition in patients with mild to moderate Alzheimer’s disease who are already receiving an acetylcholinesterase inhibitor and have been on a stable dose for at least 12 weeks. Patients will be randomized (1:1) to either daily dosing with 300 mg C-1073 or a placebo for 16 weeks. Patients will continue the stable daily dose of acetylcholinesterase inhibitor throughout the study.
Visits will be weekly at the beginning of the study, then every two weeks, and every 4 weeks after week 12. Assessments during these visits may include cognition and behavior, depression, safety, as well as physical exams, clinical laboratory tests, EKG and adverse event reporting.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Prohibited Medications:
Medications known to significantly induce or inhibit the metabolism of CYP 3A4, specifically:
United States, Arizona | |
Pivotal Research Center | |
Peoria, Arizona, United States, 85381 | |
Pivotal Research Center | |
Mesa, Arizona, United States, 85210 | |
United States, California | |
UCI Irvine Medical Center | |
Orange, California, United States, 92868 | |
California Neuroscience Research Medical Group, Inc. | |
Sherman Oaks, California, United States, 91403 | |
AVI Clinical Research | |
Torrance, California, United States, 90505 | |
ATP Clinical Trials | |
Fountain Valley, California, United States, 92708 | |
United States, Florida | |
Stedman Clinical Trials | |
Tampa, Florida, United States, 33613 | |
Clinical Physiology Associates | |
Ft. Myers, Florida, United States, 33916 | |
Baumel-Eisner Neuromed Inst | |
Ft. Lauderdale, Florida, United States, 33321 | |
Baumel-Eisner Neuromed Inst | |
Miami Beach, Florida, United States, 33154 | |
Baumel-Eisner Neuromed Inst | |
Boca Raton, Florida, United States, 33486 | |
Johnnie B. Byrd, Sr. Alzheimer's Center & Research Inst | |
Tampa, Florida, United States, 33647 | |
United States, New Jersey | |
Memory Enhancement Center | |
Long Branch, New Jersey, United States, 07740 | |
United States, New York | |
Eastside Medical Research | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Neuro Center of Ohio | |
Toledo, Ohio, United States, 43623 | |
United States, Oklahoma | |
Clinical Pharmaceutical Trials, Inc. | |
Tulsa, Oklahoma, United States, 74104 | |
Pahl Pharmaceutical Research, LLC | |
Oklahoma City, Oklahoma, United States, 73118 | |
United States, Pennsylvania | |
Clinical Trials Research Services | |
Pittsburgh, Pennsylvania, United States, 15206 | |
United States, Texas | |
Grayline Clinical Drug Trials | |
Wichita Falls, Texas, United States, 76309 | |
United States, Virginia | |
International Clinical Research Associates | |
Richmond, Virginia, United States, 23229 | |
International Clinical Research Associates | |
Virginia Beach, Virginia, United States, 23452 |
Study ID Numbers: | IA0069 |
Study First Received: | March 4, 2005 |
Last Updated: | September 28, 2005 |
ClinicalTrials.gov Identifier: | NCT00105105 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Alzheimers cognition acetyl cholinesterase inhibitor GR-II antagonist |
Neurotransmitter Agents Contraceptive Agents Hormone Antagonists Contraceptives, Oral Alzheimer Disease Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Central Nervous System Diseases Mifepristone Contraceptives, Postcoital |
Brain Diseases Neurodegenerative Diseases Cholinergic Agents Hormones Cognition Disorders Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Dementia Delirium |
Contraceptives, Postcoital, Synthetic Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Contraceptive Agents Hormone Antagonists Physiological Effects of Drugs Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Reproductive Control Agents Neurodegenerative Diseases Brain Diseases Cholinergic Agents Mental Disorders Therapeutic Uses |
Abortifacient Agents Menstruation-Inducing Agents Contraceptives, Oral, Synthetic Dementia Abortifacient Agents, Steroidal Nervous System Diseases Alzheimer Disease Central Nervous System Diseases Enzyme Inhibitors Mifepristone Luteolytic Agents Contraceptives, Postcoital Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders |