Passive Immunization Study
Enrollment — Closed
Where is this study being conducted?
Baylor College of Medicine is one of about 30 sites in the U.S. participating in this trial. This study will involve a total of 180 people nationwide. About 10 people will be enrolled at Baylor College of Medicine.
What is the purpose of this study?
AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other usually harmful substances in the body). The purpose of this clinical trial is to determine the safety, tolerability, and effectiveness of AAB-001 to slow the progression of Alzheimer's disease.
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 85 years old
- Has a diagnosis of Alzheimer's scoring between 16-26 on the Mini-Mental Status Exam (MMSE) which is a brief (5-10 min) test of memory and thinking ability
- Has a reliable caregiver (study partner) 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 (ECG). If accepted into the study, individuals will be asked to return to the clinic to receive study medication by infusion into a vein in the arm, on six separate occasions, once every 13 weeks over a period of 65 weeks. Individuals will also be asked to return to the clinic for additional visits (so that they can be monitored by the study doctor) for 52 more weeks. The total duration of the study is 27 months. Overall, persons in the study will undergo six visits to receive study medication or placebo. There will be seven visits (separate from the six infusion visits), for memory and thinking ability tests. Brain MRIs will be conducted five times and ECGs will also be done five times. On 11 out of the 25 visits, persons will have physical and neurological exams done to monitor their general health. Vital signs will be examined on 24 visits. Blood will be drawn a total of 11 times.
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. Approximately half of the subjects will be given AAB-001 and the other half will receive a placebo (inactive substance). For example, out of nine individuals, five persons are likely to receive 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, Reminyl, or Vitamin E), 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?
AAB-001 is an investigational drug and all of the possible side effects are not fully known. Until now, only one research study with AAB-001 in humans has been started (and is still ongoing), and this means that experience with AAB-001 in humans is limited. The study medication that is being used in this study, AAB-001 is a protein, and this means there is a risk of allergic reactions. Allergic reactions can range from mild (rash, itching, swelling, or numbness) to severe (for example, low blood pressure, difficulty breathing, shock, heart attack or death). 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