| Sponsor |
Pfizer, Inc. and Alzheimer’s Disease Cooperative Study (ADCS) |
| Official Study Title |
A Phase II, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of Eighteen Months of Treatment with PF-04494700 (TTP488) in Participants with Mild-to-Moderate Alzheimer’s Disease |
| Conditions Studied |
Mild-Moderate Alzheimer's disease |
| Intervention |
PF-04494700 (formerly TTP488) is an oral compound formulated to prevent
amyloid beta from binding to the RAGE receptor (receptor for advanced glycation endproducts) |
| Purpose |
To determine the efficacy and safety of 18 months of treatment with
PF-04494700 at high and low dose levels. |
| Inclusion Criteria |
Subjects must be at least 50 years old, meet criteria for Alzheimer's disease,
and have a study partner who sees them at least 3 times a week be able to accompany them to all study
visits. Subjects may take Aricept, Exelon, Razadyne and/or Namenda but must be on stable doses of these
medications for 3 months. Subjects must be willing and able to have brain MRIs or CT scans through the
course of the study. Subjects must also have an MMSE score between 14 and 26, inclusive, at time of
screening. |
| Exclusion Criteria |
History of stroke or seizures, Diabetes Mellitus Type 1 or 2, or autoimmune
disease. History of heart attack or unstable coronary artery disease in past 6 months, or cancer in last
5 years. Current pulmonary disease. Chronic NSAID use within 90 days of screening. |
| Testing |
Neurological and physical examinations, MRIs or CTs, Chest X-ray, lumbar
punctures (optional), cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen
collection, vital signs, genetic testing. |
| Frequency of Visits |
12 visits over 22 months. (~1 visit every 4-12 weeks) |
| Materials Needed Prior to Evaluation |
Diagnosis of probable Alzheimer's disease |
| Costs |
None. Parking will be validated for the Millberry Parking Garage at UCSF for
all study visits, and subjects will be reimbursed $20 per visit for meal and travel expenses. |
