Mifepristone as Adjunctive Therapy in Alzheimer's Disease

Stopped early · Phase 2

Conditions studied: Alzheimer's Disease

In brief

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).

Key facts

Study ID

NCT00105105

Run by

Corcept Therapeutics

People needed

160

Starts

2003-04-01

Expected to finish

2005-11-01

Last updated by the study team

2009-12-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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®)

Where it is running

• 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

Full record on ClinicalTrials.gov

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