Mifepristone as Adjunctive Therapy in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00105105
Recruitment Status : Terminated
First Posted : March 7, 2005
Last Update Posted : December 11, 2009
Institute for the Study of Aging (ISOA)
Information provided by:
National Institute on Aging (NIA)

March 4, 2005
March 7, 2005
December 11, 2009
April 2003
November 2005   (Final data collection date for primary outcome measure)
effects on cognition
Same as current
Complete list of historical versions of study NCT00105105 on Archive Site
effects on behavior and activities of daily living
Same as current
Not Provided
Not Provided
Mifepristone as Adjunctive Therapy in Alzheimer's Disease
A Double-blind, Placebo-controlled Trial of the Safety and Efficacy of C-1073 (Mifepristone) as Adjunctive Therapy in Alzheimer's Disease
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).

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Mifepristone
Not Provided
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 Identifier (NCT Number) in Medline.
Same as current
November 2005
November 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of Alzheimer's disease
  • Women must have had a partial or complete hysterectomy
  • Mini Mental Status Evaluation score of 18-27
  • HAM-D score less than or equal to 18
  • Able to provide written informed consent
  • On a stable dose of an acetylcholinesterase inhibitor for at least 12 weeks prior to screening visit
  • Ambulatory, or ambulatory with walker or cane
  • Sufficient hearing and vision to enable the patient to comply with the study procedures
  • Caregiver available to participate in the assessment of the patient and monitor dosing

Exclusion Criteria:

  • Women with an intact uterus
  • A clinically significant medical condition, including lab abnormality, which in the opinion of the investigator would place the patient at undue risk, or would impair the patient's ability to participate in the study. These include but are not limited to: history of cerebral vascular accident (CVA), adrenal insufficiency, porphyrias, autoimmune disorders, type I diabetes, chronic obstructive pulmonary disease (COPD), hematologic or oncologic disorders in the previous 2 years, vitamin B12 or folate deficiency
  • A clinically significant active gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease that is not well controlled by diet, pharmacological treatment, or other therapeutic intervention
  • History of psychotic episodes or bipolar disorder, or additional diagnosis of delusions, delerium, or depression
  • Evidence of other psychiatric or neurologic disorders (e.g., stroke, schizophrenia, or Parkinson disease)
  • Hachinski ischemia score of 5 or more
  • Known hypersensitivity to cholinesterase inhibitors
  • Use of systemic or pulmonary inhaled corticosteroids within the 30 days prior to randomization, or require use of these medications during the study
  • Use of memantine (Namenda) within the 30 days prior to randomization, or require use of this medication during the study
  • Currently taking medications known to significantly induce or inhibit the metabolism of CYP 3A4, or have taken these medications 7 days prior to randomization (see list below under prohibited medications)
  • Use of anticholinergic compounds within the 30 days prior to randomization, or require use of this medication during the study
  • History of electroconvulsive therapy (ECT); patients may not undergo ECT during the course of the trial
  • Positive urine drug screen for any non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
  • History of illicit drugs usage or a history of drug or alcohol dependence
  • Known to have another form of dementia that may also explain the patient's deficits including reversible dementias, Binswanger's, Parkinson's dementia complex, Korsakoff's, mental retardation or vascular dementia. Patients who meet clinical criteria for AD but who have deep white matter lesions on MRI or CT scan will be accepted.
  • Currently taking prescription anticoagulants such as warfarin (Coumadin)
  • Planned surgical procedures during the study period, including the 4 week off drug period between weeks 16 and 20
  • Participation in a clinical investigation of any drug, or other biological or investigational therapy within 30 days prior to dosing
  • Previous participation in a trial using mifepristone, or known sensitivity or allergy to C-1073 (mifepristone) or its constituents
  • Body Mass Index (BMI) over 35

Prohibited Medications:

Medications known to significantly induce or inhibit the metabolism of CYP 3A4, specifically:

  • carbamazepine (Carbatrol® Tegretol®)
  • modafinil (Provigil®)
  • nefazodone (Serzone®)
  • droperidol
  • erythromycin
  • fluconazole (Diflucan®)
  • itraconazole (Sporanox®)
  • ketoconazole (Nizoral®)
  • simvastatin (Zocor®)
  • lovastatin (Mevacor®)
  • vinblastine
  • vincristine
  • paclitaxel (Taxol®)
  • tamoxifen (Nolvadex®)
  • cyclosporine (Neoral®, Sandimmune®)
  • tacrolimus (Gengraf®)
  • sirolimus (Rapamune®)
  • midazolam (Versed®)
  • nicardipine (Cardene®)
  • nifedipine (Adalat®, Procardia®)
  • felodipine (Lexxel®, Plendil®)
  • thioridizine
  • pimozide (Orap®)
  • quinidine
  • Patient may also not take St. John's Wort during the study or within 7 days prior to study entry
  • the use of grapefruit juice will be excluded during the course of the study.
  • use of anticholinergic compounds over the past 30 days prior to randomization
  • warfarin (Coumadin)
  • all systemic and inhaled pulmonary corticosteroids
  • memantine (Namenda)
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
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Corcept Therapeutics
Institute for the Study of Aging (ISOA)
Not Provided
National Institute on Aging (NIA)
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP