Open Label Study of the Effect of Daily Treatment with MPC-7869 in Subjects withDementia of the Alzheimer’s Type

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1661

Inclusion Criteria

Subjects must meet all of the following inclusion criteria during screening in order to
participate in the study:
1. Completed, without protocol violations, a Myriad Pharmaceuticals, Inc MPC-7869
clinical trial for Alzheimer’s Disease.
OR
Discontinued from the Phase 3 trial, MPC-7869-04-005, solely due to MMSE
score =19.
OR
Were scheduled for screening prior to cessation of enrollment for MPC-7869-05-
010 and continues to meet all applicable inclusion/exclusion criteria for MPC-
7869-05-010,

Subjects who were scheduled for screening for the MPC-7869-05-010 study
must also meet the following criteria:
a. 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.
b. 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.
c. Have a screening MMSE score = 20 and = 26.
d. Have a screening Modified Hachinski Ischaemic score < 4.
e. 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).
f. Female subjects must be surgically sterile or postmenopausal for > 1 year.
2. Signed the subject Informed Consent Form (ICF) and is willing and able to
participate in the study.
3. Chronic aspirin use will be limited to cardioprotective therapy (eg, =325 mg
aspirin per day) for the duration of the study.
4. Must have a reliable caregiver.
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:
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. Chronic use of NSAIDs at any dose or aspirin >325 mg per day, taken on more
than 7 days per month.
4. History of upper GI bleeding requiring surgery and/or transfusion within the past
3 years.
5. Documented evidence of active gastric or duodenal ulcer disease within the past
3 months.
6. History of NSAID associated ulcers.
7. Chronic or acute renal, hepatic or metabolic disorder defined by:
1. Creatinine > 1.5 mg/dL
A. For Creatinine greater than 1.5 mg/dL a Creatinine
clearance should be within normal limits.
2. AST > 2.5 x Upper Limit of Normal (ULN)
3. ALT > 2.5 x ULN
8. Uncontrolled cardiac conditions (New York Heart Association Class III or IV, as
described in Appendix D).
9. Treatment with any CYP2C9 inhibitor within a 2-week period prior to enrollment.
The following drugs and herbal preparations are examples of CYP2C9 inhibitors:
amiodarone, fluconazole, fluvoxamine, isoniazid, phenylbutazone, probenicid,
sulfamethoxazole, sulfaphenazole, trimethoprim, zafirlukast; danshen (Salvia
miltiorrhiza); Lycium barbarum.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of long term treatment with MPC-7869;Secondary Objective: ;Primary end point(s): Safety endpoints include incidence and severity of adverse events (AEs), changes in physical examinations, vital sign measurements, ECGs, and clinical laboratory test results and will be monitored on an ongoing basis by the DMC.

Secondary Outcome Measures

Name	Time	Method

Updated 5/13/2024