Mild to Moderate Alzheimer's Disease Trial with ACC-001

Summary

Study director: Adam Boxer, MD, PhD
Sponsor: Wyeth Pharmaceuticals, Inc.
Recruiting?: Closed to enrolled, but continuing follow-up
Official study title: Multicenter, Randomized, Third-Party Unblinded, Multiple Ascending Dose, Safety, Tolerability, and Immunogenicity Trial of ACC-001 in Subjects With Mild to Moderate Alzheimer's Disease.
ClinicalTrials.gov identifier: NCT00498602
Conditions studied: Mild to moderate Alzheimer's disease
Intervention Drugs: ACC-001 and placebo control. ACC-001 is a protein administered via intramuscular injection designed to act like a vaccine to stimulate the body to produce antibodies to amyloid protein (the presumed cause of Alzheimer's disease) and help remove amyloid protein from the brain.
Phase: Phase II
Purpose: The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease.

Inclusion criteria: Subjects must be between 50 and 85 years old, meet criteria for mild to moderate Alzheimer's disease and have a study partner who sees them at least 5 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 4 months. Subjects must be willing and able to have brain MRIs and two lumbar punctures through the course of the study. Subjects must also have an Mini Mental State Examination (MMSE) score between 16 and 26, inclusive, at time of screening.
Exclusion criteria: History of stroke or seizures, history of substance abuse or heart attack within the last 2 years or most types of cancer within the last 5 years. Current treatment with anticoagulant (blood thinners) medication, anti-seizure medication or narcotic medications. Pacemakers, shrapnel or other metal implants in body also exclude subjects from participating.

Testing: Neurological and physical examinations, MRIs, lumbar punctures, cognitive testing and neuropsychiatric assessments, EKGs, blood and urine specimen collection, vital signs, genetic testing
Frequency of visits: 24 visits over 24 months (~1 visit every 2-6 weeks)
Materials needed prior to evaluation: Diagnosis of probable Alzheimer's disease
Costs: No costs will be charged for any of the study procedures. Parking will be validated for Millberry Parking Garage at UCSF for all study visits, and subjects will be reimbursed $25 per visit for meal and travel expenses.