Mifepristone as Adjunctive Therapy in Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
Institute for the Study of Aging (ISOA)
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00105105
First received: March 4, 2005
Last updated: December 10, 2009
Last verified: September 2005
  Purpose

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
Alzheimer's Disease
Drug: Mifepristone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Trial of the Safety and Efficacy of C-1073 (Mifepristone) as Adjunctive Therapy in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • effects on cognition

Secondary Outcome Measures:
  • effects on behavior and activities of daily living

Estimated Enrollment: 160
Study Start Date: April 2003
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105105

Locations
United States, Arizona
Pivotal Research Center
Mesa, Arizona, United States, 85210
Pivotal Research Center
Peoria, Arizona, United States, 85381
United States, California
ATP Clinical Trials
Fountain Valley, California, United States, 92708
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
United States, Florida
Baumel-Eisner Neuromed Inst
Boca Raton, Florida, United States, 33486
Baumel-Eisner Neuromed Inst
Ft. Lauderdale, Florida, United States, 33321
Clinical Physiology Associates
Ft. Myers, Florida, United States, 33916
Baumel-Eisner Neuromed Inst
Miami Beach, Florida, United States, 33154
Stedman Clinical Trials
Tampa, Florida, United States, 33613
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
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, United States, 73118
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, United States, 74104
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
Sponsors and Collaborators
Corcept Therapeutics
Institute for the Study of Aging (ISOA)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00105105     History of Changes
Other Study ID Numbers: IA0069
Study First Received: March 4, 2005
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):
Alzheimers
cognition
acetyl cholinesterase inhibitor
GR-II antagonist

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Mifepristone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents

ClinicalTrials.gov processed this record on September 14, 2014