Alzheimer's DiseasePhase 2NCT00105105
Mifepristone as Adjunctive Therapy in Alzheimer's Disease
A Phase 2 study testing Mifepristone in people with Alzheimer's Disease, run by Corcept Therapeutics at 21 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Mifepristone
- How many people
- 160 participants
- Where
- 21 sitesUnited States
- Study dates
- Apr 2003to Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 52Show fewer
- 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)
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Baumel-Eisner Neuromed Inst
Boca Raton, Florida, 33486
Baumel-Eisner Neuromed Inst
Fort Lauderdale, Florida, 33321
Clinical Physiology Associates
Fort Myers, Florida, 33916
ATP Clinical Trials
Fountain Valley, California, 92708
Memory Enhancement Center
Long Branch, New Jersey, 07740
Pivotal Research Center
Mesa, Arizona, 85210
Baumel-Eisner Neuromed Inst
Miami Beach, Florida, 33154
Eastside Medical Research
New York, New York, 10021
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118
UCI Irvine Medical Center
Orange, California, 92868
Pivotal Research Center
Peoria, Arizona, 85381
Clinical Trials Research Services
Pittsburgh, Pennsylvania, 15206
International Clinical Research Associates
Richmond, Virginia, 23229
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
Stedman Clinical Trials
Tampa, Florida, 33613
Johnnie B. Byrd, Sr. Alzheimer's Center & Research Inst
Tampa, Florida, 33647
Neuro Center of Ohio
Toledo, Ohio, 43623
AVI Clinical Research
Torrance, California, 90505
Clinical Pharmaceutical Trials, Inc.
Tulsa, Oklahoma, 74104
International Clinical Research Associates
Virginia Beach, Virginia, 23452
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
About this study
Official title: 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).
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- Mifepristone
- Keywords
- Alzheimers, cognition, acetyl cholinesterase inhibitor, GR-II antagonist
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
effects on cognition
Secondary outcomes (1)
effects on behavior and activities of daily living
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2005 (estimated)
- Study startApr 2003
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institute for the Study of Aging (ISOA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105105
- Sponsor's protocol ID
- IA0069
- Status last verified
- Sep 2005
- First submitted
- 4 Mar 2005
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
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.
PubMed 12212781
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Trial of the Safety and Efficacy of C-1073 (Mifepristone) as Adjunctive Therapy in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00105105
- Acronym / sponsor ID
- IA0069
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimers, cognition, acetyl cholinesterase inhibitor, GR-II antagonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 160 participants
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Institute for the Study of Aging (ISOA)
- Study start
- Apr 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 7 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (52 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone | Drug | – |
Primary outcome
effects on cognition
1 secondary outcome
effects on behavior and activities of daily living
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Background: PubMed 12212781Belanoff 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.
- Corcept TherapeuticsLink provided by the sponsor.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone in people with Alzheimer's Disease, run by Corcept Therapeutics at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effects on cognition. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.