Treatment of Alzheimer’s disease MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Name: Tarenflurbil
Product Code: MPC-7869
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tarenflurbil
CAS Number: 51543-40-9
Current Sponsor code: MPC-7869
Other descriptive name
Sponsors
Myriad Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria during screening in order to participate in the study: 1. Completed, without protocol violations, a Myriad Pharmaceuticals, Inc MPC-7869 clinical trial for Alzheimer’s Disease. OR Discontinued from the Phase 3 trial, MPC-7869-04-005, solely due to MMSE score =19. OR Were scheduled for screening prior to cessation of enrollment for MPC-7869-05- 010 and continues to meet all applicable inclusion/exclusion criteria for MPC- 7869-05-010, Subjects who were scheduled for screening for the MPC-7869-05-010 study must also meet the following criteria: a. Have had a diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders – Fourth Edition (text revised) (DSM IV [TR]), as described in Appendix B, and meet the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer’s disease, as described in Appendix C. b. Have a computed tomography (CT) or magnetic resonance imaging (MRI) within the past 12 months, demonstrating absence of clinically significant focal intracranial pathology. If no scan is available in the previous 12 months, then a CT or MRI scan will be obtained. c. Have a screening MMSE score = 20 and = 26. d. Have a screening Modified Hachinski Ischaemic score 1 year. 2. Signed the subject Informed Consent Form (ICF) and is willing and able to participate in the study. 3. Chronic aspirin use will be limited to cardioprotective therapy (eg, =325 mg aspirin per day) for the duration of the study. 4. Must have a reliable caregiver. 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
Exclusion criteria
Exclusion criteria: Subjects with any of the following exclusion criteria may not participate in the study: 1. 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 than 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety endpoints include incidence of adverse events (AEs), changes in physical examinations, and clinical laboratory test results.;Main Objective: To evaluate the safety of long term treatment with MPC-7869;Secondary Objective: | — |
Countries
Denmark, France, Germany, Italy, Netherlands, Sweden
Outcome results
None listed