The purpose of this research study is to learn if the investigational product ABBV-8E12 (an anti-tau antibody) can block spreading of tau protein in the brain and slow down Alzheimer's Disease.
Research has shown that abnormal tau protein in the brain can stop brain cells from doing their job and cause them to die.
This study will also look at the long-term safety of ABBV-8E12 for up to 96 weeks.
Why should I consider participating?
Individuals who participate in clinical research are vital in helping researchers develop potential new treatments for medical conditions. As a study participant, you will be monitored by the study physician. Additionally, throughout your participation in a clinical research study, you will receive study-required medical care and monitoring at no cost. Although you may not benefit directly from participating in the research study, the information gathered in the study may help patients with Early Alzheimer's Disease in the future.
What is the investigational study medication?
The investigational study medication is called ABBV-8E12 and is given by intravenous (IV) infusion. The investigational study medication is not approved by regulatory agencies for the treatment of any disease or condition. In this study, the investigational study medication will be compared to a placebo. The placebo will be a saline solution that will be given by the intravenous (IV) infusion. The placebo looks the same as the investigational study medication but does not contain any active drug components.
What should I expect during this research study?
You will undergo an initial screening period with visit procedures including, but not limited to, blood work, neurological testing, and MRI. If you qualify then additional screening procedures such as PET scan and lumbar puncture will be performed to determine if you meet the clinical criteria for early Alzheimer's Disease and qualify for the study. You will be administered a series of questionnaires to assess your memory, thinking skills and activities of daily living. If you are eligible, you will receive the first infusion of the investigational study medication by intravenous (IV) infusion. The study doctors and staff respect your privacy. Details about your health will not be shared with anyone who is not associated with this research study unless you have given your permission or as required by law.
How do you decide whether I will receive the study medicine or the placebo?
If you are able to participate in this research study, you will be randomly assigned to receive either the investigational study medication or placebo. You have a 75% (3 in 4) chance of receiving the investigational study medication and a 25% (1 in 4) chance of receiving the placebo.
How long is this research study?
Your participation in the study may last up to about 2 plus years (124 weeks). This study has
• an 8-week screening period
• a 96-week study drug dosing period and
• a 16-week follow-up period
You may be able to join the study if you:
• Are between 55 to 85 years of age
• Meet specific clinical criteria for mild cognitive impairment or probable Alzheimer's Disease.
• Have an identified study partner who is willing to support you in this study, come to study visits and provide information about your well-being
• Are able and willing to have brain imaging such as magnetic resonance imaging (MRI) and Positron Emission Tomography (PET) scan, and to undergo lumbar punctures.
• Do not have other psychiatric or neurologic disorders
The study doctor will discuss with you these and other requirements to determine if you are able to participate in this research study. Talk with your own personal doctor as well as your partner, family and friends before deciding if the study is right for you.