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

Myriad Pharmaceuticals, Inc0 sites800 target enrollmentApril 20, 2006

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 20, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Myriad Pharmaceuticals, Inc

Eligibility 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 \<\=26\.
•\-Have a screening Modified Hachinski Ischaemic score \<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).
•\-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 \<\= 325 mg aspirin per day) for the duration of the study.

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