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Research
Introduction
MAC Research
Autopsy Program
Healthy Volunteering
Investigator Requests
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A Third-Party Unblinded, Adjuvant-Controlled Study to Determine Safety and Tolerability of ACC-001 in Subjects with Alzheimer's Disease
| Study Director |
Adam Boxer, MD, PhD |
| Sponsor |
Wyeth Pharmaceuticals, Inc. |
| Recruiting? |
Yes |
| Official Study Title |
A phase IIa, multicenter, randomized, third-party unblinded,
adjuvant-controlled, multiple ascending dose, safety, tolerability and immunogenicity trial of
ACC-001 with QS-21 adjuvant in subjects with mild to moderate Alzheimer's disease. |
| Conditions studied |
Mild-moderate Alzheimer's disease |
| Intervention |
CC-001, a protein administered via intramuscular injection,
is 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. |
| Purpose |
To determine safety and tolerability of multiple ascending doses
of ACC-001. |
| Eligibility |
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| Inclusion Criteria |
Subjects must be between 50 and 85 years old, meet criteria for
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 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. |
| What is Involved? |
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| 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) |
| Contact Information |
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| Coordinator |
Jessica Hall |
| Phone |
(415) 476-0700 |
| 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 $25 per visit for meal and travel expenses. |
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