Passive Immunization Study (Phase 3)
Enrollment — Closed
IRB Number: H-25937
A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety trial of bapineuzumab (AAB-001, ELN115727) in patients with mild to moderate Alzheimer's disease
Where is this study being conducted?
Baylor College of Medicine is one of about 200 sites in the U.S. participating in this trial. This study will involve a total of 2,050 people nationwide, about 40 people will be enrolled at BCM.
What is the purpose of this study?
The purpose of this study is to determine the efficacy, safety, tolerability, and effectiveness of a new drug to slow the progression of Alzheimer's disease. This new drug is an Amyloid Antibody that is not available outside this study. An antibody is a type of protein usually produced by white blood cells to destroy other usually harmful substances in the body.
Who is the sponsor?
Elan Pharmaceuticals, Inc.
Who is eligible to participate?
A person may be eligible to participate if he or she:
- Is male or female aged between 50 to <89 years old
- Has a diagnosis of Alzheimer's disease, with a score of 16-26 on the Mini-Mental Status Exam (MMSE)
- Has contact with a reliable caregiver (at least five days a week) who can accompany them to study visits
- Speaks English fluently and is in generally good physical health.
What is involved for individuals who wish to participate?
At an initial screening visit (to determine eligibility), medical history will be reviewed and the following evaluations performed: vital signs, physical examination, brief memory assessment, lab work (blood and urine tests), and an electrocardiogram. A portion of your blood will be used to determine whether/not you have the E4 allele and you'll be assigned to either of two studies. Individuals will be asked to return to the clinic to receive study medication or placebo by infusion into a vein in the arm, on six separate occasions, and the total duration of the study is 18 months. There will be other visits (separate from the six infusion visits), for memory and thinking ability tests, brain MRIs, ECGs and physical and neurological exams done to monitor their general health. Vital signs will be examined on all visits. Blood will be also be drawn at certain visits.
What is the study design?
This is a randomized, double-blind, placebo-controlled study. This means that participants will be randomly assigned (by chance) to one of two groups (study drug or placebo). More than half of the subjects will be given the study drug while others will receive a placebo (inactive substance). For example, out of 10 individuals, six persons are likely to receive active study medication and the remaining four will receive placebo. Double-blind means that neither the participants nor the research team will know to which group each subject has been assigned.
Can participants in this study continue taking their regular medications?
Yes, in general, subjects may continue taking their regular Alzheimer's medications (such as Aricept, Exelon, Razadyne, or Namenda), provided that the dosage has been stable for at least four months prior to entry in the study. There are some medications (prescription and non-prescription) that are not allowed in this study. The study doctor will let you know which medications are not allowed in this study.
Are there any risks associated with this study?
This study drug is an investigational drug and all of the possible side effects are not fully known. Experience with the study drug in humans is limited. The study medication is a protein, and this means there is a risk of allergic reactions. Your study doctor will be prepared to treat an allergic reaction should one occur.
Where can I get more information?
Contact: Sayo Awosika-Olumo, M.B.B.S., M.P.H. at Baylor College of Medicine