Mifepristone as Adjunctive Therapy in Alzheimer's Disease
NCT ID: NCT00105105
Last Updated: 2009-12-11
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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TERMINATED
PHASE2
160 participants
INTERVENTIONAL
2003-04-30
2005-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Mifepristone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
No
Sponsors
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Institute for the Study of Aging (ISOA)
OTHER
Corcept Therapeutics
INDUSTRY
Locations
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Pivotal Research Center
Mesa, Arizona, United States
Pivotal Research Center
Peoria, Arizona, United States
ATP Clinical Trials
Fountain Valley, California, United States
UCI Irvine Medical Center
Orange, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
AVI Clinical Research
Torrance, California, United States
Baumel-Eisner Neuromed Inst
Boca Raton, Florida, United States
Baumel-Eisner Neuromed Inst
Fort Lauderdale, Florida, United States
Clinical Physiology Associates
Fort Myers, Florida, United States
Baumel-Eisner Neuromed Inst
Miami Beach, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Johnnie B. Byrd, Sr. Alzheimer's Center & Research Inst
Tampa, Florida, United States
Memory Enhancement Center
Long Branch, New Jersey, United States
Eastside Medical Research
New York, New York, United States
Neuro Center of Ohio
Toledo, Ohio, United States
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, United States
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, United States
Clinical Trials Research Services
Pittsburgh, Pennsylvania, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
International Clinical Research Associates
Richmond, Virginia, United States
International Clinical Research Associates
Virginia Beach, Virginia, United States
Countries
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References
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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. doi: 10.1007/s12031-002-0033-3.
Related Links
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Corcept Therapeutics
Other Identifiers
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IA0069
Identifier Type: -
Identifier Source: org_study_id