Mifepristone as Adjunctive Therapy in Alzheimer's Disease
Tracking Information | |
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First Received Date ICMJE | March 4, 2005 |
Last Updated Date | December 10, 2009 |
Start Date ICMJE | April 2003 |
Primary Completion Date | November 2005 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
effects on cognition |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00105105 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
effects on behavior and activities of daily living |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Mifepristone as Adjunctive Therapy in Alzheimer's Disease |
Official Title ICMJE | A Double-blind, Placebo-controlled Trial of the Safety and Efficacy of C-1073 (Mifepristone) as Adjunctive Therapy in Alzheimer's Disease |
Brief Summary | 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). |
Detailed Description | 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. |
Study Type ICMJE | Interventional |
Study Phase | Phase 2 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Condition ICMJE | Alzheimer's Disease |
Intervention ICMJE | Drug: Mifepristone |
Study Arm (s) | |
Publications * | Belanoff JK, Jurik J, Schatzberg LD, DeBattista C, Schatzberg AF. Slowing the progression of cognitive decline in Alzheimer's disease using mifepristone. J Mol Neurosci. 2002 Aug-Oct;19(1-2):201-6. |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Terminated |
Enrollment ICMJE | 160 |
Completion Date | November 2005 |
Primary Completion Date | November 2005 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Prohibited Medications: Medications known to significantly induce or inhibit the metabolism of CYP 3A4, specifically:
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Gender | Both |
Ages | |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States |
Administrative Information | |
NCT Number ICMJE | NCT00105105 |
Other Study ID Numbers ICMJE | IA0069 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Corcept Therapeutics |
Collaborators ICMJE | Institute for the Study of Aging (ISOA) |
Investigators ICMJE | |
Information Provided By | National Institute on Aging (NIA) |
Verification Date | September 2005 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |