Indiana Neuroimaging and Biomarker Study of Anti-Amyloid Treatments
DW
Donna Wilcock
Principal Investigator
Status: Enrolling By Invitation
Ages: 100 Years
Gender: All Genders
Phase: N/A
4 Locations
Brief Description
What is the purpose of this study?
The goal of this research is to create a repository of brain imaging and biological samples to study individuals undergoing clinical treatment with anti-amyloid therapies and compare them with samples and images from healthy individuals and cognitively impaired individuals not receiving these treatments. We expect to develop a large cohort of individuals that agree to have their information and bio samples used for research purposes in hopes of contributing to larger body of neurological and health sciences research.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants will be recruited from neurology and infusion clinics in Goodman Hall and other IU Health locations that are participating in anti-amyloid infusions. Participants may be referred to the study by their physician, the Brain Health Navigator or approached by research staff at a clinical visit.
Detailed Description
What will happen during the study?
- This repository will collect lifestyle and health information, blood and medical imaging for patients while undergoing anti-amyloid treatment as part of their clinical care.
- This will include previous dementia history, testing information to determine eligibility for anti-amyloid therapy as well as neuroimaging data collected before and during treatment with anti-amyloid therapy.
- Consented participants will have blood samples collected (approximately 1½ tablespoons at the first infusion visit and 2 teaspoons at the remaining visits) collected prior to clinical administration of anti-amyloid therapy at infusion numbers 1-8, 10,12,14,18 and 22.
- We will collect and store health information that has been gathered as part of the participant’s routine clinical care or research visit.
- Medical imaging from clinical testing will be transferred at least quarterly until five years after the participants last dose of anti-amyloid treatment.
- We will be comparing differences in brain structure and function, as well as blood-based biomarkers, in individuals who are undergoing anti-amyloid therapies who experience a major side effect (amyloid-related imaging abnormality (ARIA) or who do not.
Eligibility of study
Inclusion criteria:
1. Males and females undergoing screening for anti-amyloid therapy.
2. Willing and able to provide written informed assent/consent.
1. Males and females undergoing screening for anti-amyloid therapy.
2. Willing and able to provide written informed assent/consent.
Exclusion criteria:
1. Contraindication for anti-amyloid therapy by standard clinical criteria.
1. Contraindication for anti-amyloid therapy by standard clinical criteria.
Interested in participating?
Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Many studies only accept people who are part of an invited group. Visit allinforhealth.info to connect with the study team, or contact your doctor to see if you are eligible.