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

• Conditions: Mild Dementia of the Alzheimer's Type

• Registration Number: EUCTR2006-000654-43-DK
• Lead Sponsor: Myriad Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-28
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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.
-Subjects taking an AChE inhibitor may be enrolled provided they have been taking that specific medication at stable doses for at least 6 months prior to Day 1. Subjects not taking AChE inhibitors may be enrolled if initiation of AChE inhibitor is not anticipated during this study. Subjects previously treated with, but not currently taking, AChE inhibitors must be off drug for at least 30 days prior to screening.
-Subjects taking memantine may be enrolled provided they have been taking that specific medication at stable doses for at least 3 months prior to Day 1. Subjects not taking memantine may be enrolled if initiation of memantine is not anticipated during this study. Subjects previously treated with, but not currently taking, memantine must be off drug for at least 30 days prior to screening.
-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 subjects 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 behaviour with time, and must be prepared to verify daily compliance with study medication.
-Subjects taking antidepressant, antipsychotic, and/or anxiolytic drugs, Vitamin E and/or Gingko biloba are eligible, provided that the dose has been stable for at least 3 months prior to randomization.
-Adequate vision and hearing to participate in study assessments.
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified