Phase 3 Multinational, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment with MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects with Mild Dementia of the Alzheimer's Type

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

1. 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.
2. 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.
3. Have a screening MMSE score >=20 and <=26.
4. 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).
5. Subjects must have a reliable caregiver who can read, understand and speak English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish, and, will accompany the subject to each clinic visit, and is willing to sign the Caregiver Assent Form. Caregiver must either live with the subject or see them on at least 4 days per week, with contact sufficient to insure meaningful assessment of changes in subject behavior with time, and must be prepared to verify daily compliance with study medication.

Exclusion Criteria

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: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the change in cognition and activities of daily living, as measured<br /><br>by ADAS-cog, and ADCS-ADL in subjects with Alzheimer*s disease treated with<br /><br>MPC-7869.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess changes in cognition as measured by a Neuropsychological Test Battery<br /><br>(NTB).To assess changes in global function as measured CDR-sb.<br /><br>PC-7869.<br /><br>Safety of treatment with MPC-7869; Cerebrospinal fluid (optional) and<br /><br>peripheral blood analysis for potential biomarkers; Population pharmacokinetics<br /><br>of MPC-7869.</p><br>

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