Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects with Dementia of the Alzheimer*s Type.
- Conditions
- Dementia10012272Alzheimer's disease
- Registration Number
- NL-OMON31593
- Lead Sponsor
- Myriad Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 11
1. Completed, without protocol violations, a Myriad Pharmaceuticals, Inc MPC-7869 clinical trial for Alzheimer's disease.
2. 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.
3. 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.
4. Have a screening MMSE score *20 and *26.
5. Have a screening Modified Hachinski Ischaemic score < 4.
6. Men or women ages * 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
7. Subjects must have a reliable caregiver.
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. Documented evidence of active gastric or duodenal ulcer disease within the past 3 months.
4. Chronic or acute renal, hepatic or metabolic disorder .
5. Uncontrolled cardiac conditions (New York Heart Association Class III or IV)
6. History of NSAID associated ulcers.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety effects: this includes the amount of Adverse events (AE*s), changes at<br /><br>physical examinations and results of the clinical laboratory tests. </p><br>
- Secondary Outcome Measures
Name Time Method <p>N.a.</p><br>