Indiana Neuroimaging and Biomarker Study of Anti-Amyloid Treatments

D
Donna Wilcock

Primary Investigator

Enrolling By Invitation
100 years or below
All
Phase N/A
100 participants needed
1 Location

Brief description of study

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 of study

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early-Stage Alzheimer's Disease, Mild Dementia, Mild Cognitive Impairment, MCI
  • Age: 100 years or below
  • Gender: All

Inclusion criteria:
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.

Updated on 29 Apr 2025. Study ID: NEUR-IIR-ANTI-AMYLOID, 24479
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