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A Phase 2, Multi-Center, 24-Month, Randomized, Third-Party Unblinded, Placebo-Controlled, Parallel-Group Amyloid Imaging Positron Emission Tomography (PET) and Safety Trial of ACC-001 and QS-21 Adjuvant in Subjects with Early Alzheimer's Disease
WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of this clinical trial is to evaluate the efficacy, safety and tolerability of ACC-001, a drug that has the potential to treat early Alzheimer's disease. ACC-001 is a vaccine against amyloid. In a healthy brain, amyloid is broken down and eliminated. In early Alzheimer's disease, amyloid fragments gather and from hard plaques. Doctors think that the amyloid plaques cause symptoms like memory loss and confusion.
QS-21 is an adjuvant. An adjuvant is a substance that helps to stimulate the body's immune system to produce antibodies. Antibodies are a type of protein made by white blood cells to destroy foreign substances in the body. It is hope that ACC-001 alone or when mixed with QS-21 will act a vaccine to help the body make antibodes to destroy the amyloid protein in the brain.
WHO IS ELIGIBLE?
We are looking for participants who:
* have early onset Alzheimer's disease or have changes in memory also known as Mild Cognitive Impairment (MCI)
* are between the age of 50 and 80
* have a reliable caregiver or family member who is able to accompany them to study visits
* are in stable medical condition
* are willing to undergo a lumbar puncture (spinal tap)
People taking approved Alzheimer's medications (donepezil/Aricept, galantamine/Razadyne, rivastigmine/Exelon, memantine/Namenda) are eligible to take part in this study and can continue taking these medications during the study. You do not have to be on these medications to take part in the study.
More information is attached.
Caroline A. Sullivan, BA
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