Overview

Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's

Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to evaluate the change in cognitive ability and activities of daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations during 18 months of dosing.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Myrexis Inc.
Treatments:
Flurbiprofen
Criteria
Inclusion Criteria:

- Have had a diagnosis of probable Alzheimer's disease.

- Men or women ages 55 years or greater and living in the community at the time of
enrollment (i.e., not living in a rest home or nursing care facility).

- Signed the subject Informed Consent Form and is willing and able to participate for
the duration of the study.

- Ability to read and understand English or Spanish to ensure compliance with cognitive
testing and study visit procedures.

- Female subjects must be surgically sterile or postmenopausal for > 1 year.

- Subjects currently taking approved medication for Alzheimer's disease for at least six
months prior to day 1 may be enrolled.

- Subjects must have a reliable caregiver who can read, understand and speak English or
Spanish.

Exclusion Criteria:

- Current evidence of other causes of dementia.

- History 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.

- 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.