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
1 other identifier
interventional
160
1 country
21
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2003
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 4, 2005
CompletedFirst Posted
Study publicly available on registry
March 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedDecember 11, 2009
September 1, 2005
2.6 years
March 4, 2005
December 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
effects on cognition
Secondary Outcomes (1)
effects on behavior and activities of daily living
Interventions
Eligibility Criteria
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.
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corcept Therapeuticslead
- Institute for the Study of Aging (ISOA)collaborator
Study Sites (21)
Pivotal Research Center
Mesa, Arizona, 85210, United States
Pivotal Research Center
Peoria, Arizona, 85381, United States
ATP Clinical Trials
Fountain Valley, California, 92708, United States
UCI Irvine Medical Center
Orange, California, 92868, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
AVI Clinical Research
Torrance, California, 90505, United States
Baumel-Eisner Neuromed Inst
Boca Raton, Florida, 33486, United States
Baumel-Eisner Neuromed Inst
Fort Lauderdale, Florida, 33321, United States
Clinical Physiology Associates
Fort Myers, Florida, 33916, United States
Baumel-Eisner Neuromed Inst
Miami Beach, Florida, 33154, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Johnnie B. Byrd, Sr. Alzheimer's Center & Research Inst
Tampa, Florida, 33647, United States
Memory Enhancement Center
Long Branch, New Jersey, 07740, United States
Eastside Medical Research
New York, New York, 10021, United States
Neuro Center of Ohio
Toledo, Ohio, 43623, United States
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118, United States
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, 74104, United States
Clinical Trials Research Services
Pittsburgh, Pennsylvania, 15206, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
International Clinical Research Associates
Richmond, Virginia, 23229, United States
International Clinical Research Associates
Virginia Beach, Virginia, 23452, United States
Related Publications (1)
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.
PMID: 12212781BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 4, 2005
First Posted
March 7, 2005
Study Start
April 1, 2003
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
December 11, 2009
Record last verified: 2005-09