Title: Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer?s Type - ND
- Conditions
- Dementia of the Alzheimer?s typeMedDRA version: 9.1Level: LLTClassification code 10012271Term: Dementia Alzheimer's type
- Registration Number
- EUCTR2007-003362-17-IT
- Lead Sponsor
- Myriad Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1661
Eligible subjects must have completed, without protocol violations, a Myriad Pharmaceuticals, Inc MPC-7869 clinical trial for Alzheimer?s disease (AD) and qualify based on all inclusion and exclusion criteria. OR Discontinued from the Phase 3 trial, MPC-7869-04-005, solely due to MMSE score ≤ 19 and qualify based on all inclusion and exclusion criteria. OR Were scheduled for screening prior to cessation of enrollment for MPC-7869-05-010 and continue to qualify based on all applicable inclusion and exclusion criteria for MPC-7869-05-010.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injuries, or DSM-IV (TR) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse. 2. History of hypersensitivity to flurbiprofen or other NSAIDs including COX-2 specific inhibitors. 3. Chronic use of NSAIDs at any dose or aspirin >325 mg per day, taken on more than 7 days per month. 4. History of upper GI bleeding requiring surgery and/or transfusion within the past 3 years. 5. Documented evidence of active gastric or duodenal ulcer disease within the past 3 months. 6. History of NSAID associated ulcers. 7. Chronic or acute renal, hepatic or metabolic disorder defined by: 1. Creatinine > 1.5 mg/dL A. For Creatinine greater then 1.5 mg/dL a Creatinine clearance should be within normal limits. 2. AST > 2.5 x Upper Limit of Normal (ULN) 3. ALT > 2.5 x ULN 8. Uncontrolled cardiac conditions (New York Heart Association Class III or IV, as described in Appendix D). 9. Treatment with any CYP2C9 inhibitor within a 2-week period prior to enrollment. The following drugs and herbal preparations are examples of CYP2C9 inhibitors: amiodarone, fluconazole, fluvoxamine, isoniazid, phenylbutazone, probenicid, sulfamethoxazole, sulfaphenazole, trimethoprim, zafirlukast; danshen (Salvia miltiorrhiza); Lycium barbarum.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety of long term treatment with MPC-7869;Secondary Objective: -;Primary end point(s): Safety endpoints include incidence of adverse events (AEs), changes in physical examinations, and clinical laboratory test results
- Secondary Outcome Measures
Name Time Method