Mild Dementia of the Alzheimer's Type
Conditions
Interventions
Product Name: (R)-(-)-flurbiprofen
Product Code: MPC-7869
Pharmaceutical Form: Film-coated tablet
CAS Number: 51543-40-9
Current Sponsor code: MPC-7869
Other descriptive name: (R)-(-)-flurbiprofen
Con
Sponsors
Myriad Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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 descibed in Appendix C. -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. -Have a screening MMSE score >= 20 and =55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility). -Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study. -Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures. -At least 6 years of education, or sufficient work history to exclude mental retardation. -Female subjects must be surgically sterile or postmenopausal for >1 year. -Chronic aspirine use will be limited to cardioprotective therapy (eg =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: -Current evidence or history in the past 2 years of epilepsy, focal brain lesion, head injury, or DSM-IV (TR) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse. -History of hypersensitivity to flurbiprofen or other NSAIDs, including COX-2 specific inhibitors. -Chronic use of NSAIDs at any dose or aspirin >325 mg per day, taken on more than 7 days per month for the 2 months prior to Day 1. -History of upper GI bleeding requiring surgery and/or transfusion within the past 3 years. -Documented evidence of active gastric or duodenal ulcer disease within the past 3 months. -History of NSAID associated ulcers. -History of, or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor. -Chronic or acute renal, hepatic or metabolic disorder defined by: -Creatinine >1.5 mg/dL -AST >2.5 x Upper Limit of Normal (ULN) -ALT >2.5 x ULN -Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening. -Major surgery and related complications not resolved within 12 weeks prior to Day 1. -Uncontrolled cardiac conditions (New York Heart Association Class III or IV, as described in Appendix D). -Anticoagulant therapy such as warfarin within 12 weeks prior to Day 1. -Treatment with any CYP2C9 inhibitor within a 2-week period to Day 1. The following drugs and herbal preparations are examples of CYP2C9 inhibitors: amiodarone, fluconazole, fluvoxamine, isoniazid, phenylbutazone, probenecid, sulfamethoxazole, sulfaphenazole, trimethoprim, zafirlukast; danshen (Salvia miltiorrhiza); Lucium barbarum. -Previous participation in an MPC-7869 clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the rate of change in cognition and activities of daily living, as measured by Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog) and Alzheimer's Disease Cooperative Study, activities of daily living scale (ADAS-ADL), in subjects with Alzheimer's disease (AD) treated with MPC-7869 (R-flurbiprofen).;Secondary Objective: To assess the rate of change in cognition as measured by a Neuropsychological Test Battery (NTB). To assess the rate of change in global function as measured by Clinical Dementia Rating-sum of boxes scale (CDR-sb).;Primary end point(s): The primary efficacy endpoints are change from baseline in the ADAS-cog and the ADCS-ADL scales. | — |
Countries
Belgium, Denmark, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed