Alzheimer's Disease Connectome Project
Why is this study being done?
The purpose of the Alzheimer’s Disease Connectome Project (ADCP) is to make the most detailed measurements of brain networks to date in people with mild cognitive impairment (MCI) and Alzheimer’s disease (AD). The study will employ the most sophisticated magnetic resonance imaging (MRI) technologies available today to map connections between brain regions. To correlate the MRI findings with cognitive impairment, we will also conduct detailed testing of your cognitive abilities (such as memory, language, and concentration). Some participants will also be invited to undergo positron emission tomography (PET) to measure amyloid and tau, two proteins that become dysfunctional in the brain in Alzheimer’s disease. As part of this research study, you will also have the option to participate in a lumbar puncture (sometimes referred to as a spinal tap) to provide a small amount of your spinal fluid so that we may test it for biomarkers of AD. These markers may one day help us to prevent and treat AD.
We hope that by studying a large group of people with MCI and AD, and healthy controls, using sensitive and state-of-the-art brain imaging methods, we will discover—for the first time—how changes in brain networks may lead to the development of dementia. We hope the findings from this study will lead directly to new and powerful clinical tools for diagnosis and individualized treatment of Alzheimer’s disease.
All of the study activities, except PET, will be available at both the Medical College of Wisconsin in Milwaukee and the University of Wisconsin in Madison. PET scans for this study will be performed only at the University of Wisconsin in Madison.
What will happen if I take part in the study?
Your participation in this study will last about four years. You have the right, however, to withdraw from the study at any time before completion, with no consequences whatsoever.
If you qualify to participate, a study coordinator will schedule you for 2-3 baseline visits, each lasting from 4-8 hours, with ample periods of rest included. We will try to schedule visits within days of each other, and work with you to determine visit dates that work with your schedule as well as considering scanner and room availability. You will need to have a study partner who is willing to answer questions about your memory functioning and activities of daily living.
Study procedures include completing a medical history interview, participating in tests of your cognitive abilities, a blood draw, physical/neurological examination, and two brain imaging sessions using MRI (to produce images of brain connectivity such as the one below). You will also be invited to participate in a lumbar puncture. Some participants will also be invited for PET scanning.
Approximately 2 years after you complete your initial visits, we will schedule a follow-up evaluation that involving the same procedures.
What side effects or risks can I expect from the study?
Magnetic resonance imaging: MRI is a way for us to see inside your brain. The risks associated with MRI are low, there are no injections, catheters, or other invasive procedures. There is no exposure to x-rays or radioactivity. However, MRI is not safe for everyone. For example, it is not safe to have an MRI scan if you have an implanted cardiac pacemaker or defibrillator. Your ability to have an MRI will be determined by our research personnel or by consulting your doctor.
Cognitive tests: These tests are used to evaluate your memory and thinking ability. They may be slightly frustrating or produce fatigue or boredom.
Blood draw: The primary risk of blood draw is local pain and bruising, or light-headedness.
Lumbar puncture: This procedure allows us to examine proteins related to Alzheimer’s disease. The most common complication of spinal fluid collection is a headache (less than 2 out of every 100-people using our technique).
PET scanning (substudy): The PET scans use very small amounts of radioactive compounds to image amyloid and tau protein buildup in the brain. An IV (needle) will be placed in a vein in your arm or hand in order to inject the compounds. The federal government has set regulations on the amount of radiation exposure that is considered safe, and these procedures are within those regulations. There are no known side effects and the compounds clear the body within a few hours.
Who is eligible?
We are seeking three groups of participants:
- People with dementia due to Alzheimer’s disease
- People with mild cognitive impairment
- Healthy older adults
You must be 55-90 years old and speak English fluently.
You must be able to undergo MRI.
Are there any costs associated with taking part in the study?
There are no costs to be in this study. Neither you nor your health insurance provider will be charged for any study related activities. You will receive a pass for free parking at the study sites during your visits.
Will I be compensated for participating in the study?
Yes. You will be paid:
- $50 for each MRI scan
- $50 for each cognitive/medical evaluation
- $100 for each (optional) lumbar puncture procedure
- $75 for each PET scan (if selected)
Your study partner will be paid $25 for his/her participation.
To participate in this study or for more information, contact:
Medical College of Wisconsin
firstname.lastname@example.org | (414) 955-0667
University of Wisconsin-Madison
email@example.com | (608) 265-7399
Barbara Bendlin, PhD | University of Wisconsin-Madison
An Invitation to Participate in Research
Shi-Jiang Li, PhD, Study Leader | Department of Biophysics, Medical College of Wisconsin, 8701 Watertown Plank Rd., Milwaukee, WI 53226