Alzheimer"s Imaging Biomarkers in Obesity
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Cyrus A Raji
- Study ID
- NCT05077579
- Status
- Recruiting
Conditions
- Alzheimer Disease
- Metabolic Disease
- Obesity
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - 60 Years
- Healthy Volunteers
- Accepted
Study Details
High body fat at midlife, as evidenced by overweight or obese body mass index (BMI), is increasingly understood as a risk factor for Alzheimer's disease. However, the underlying processes and mechanisms that may underlie this risk remains unknown. With this project, the Investigator proposes to create a new cohort of cognitively normal 120 midlife individuals, age 40-60 years. The investigator and research staff will characterize the participant's overweight or obese status using metabolic tests including, an oral glucose tolerance test, fasting plasma insulin, fasting plasma glucose, and hemoglobin A1c measurements. This testing will generate categories of metabolically abnormal overweight and obese (MAOO), metabolically normal overweight and obese (MNOO), and metabolically normal lean participants (MNLP). Research staff will evaluate differences between these groups on neuroimaging with the newer classification framework of Alzheimer's biomarkers with amyloid (A), tau (T), and neurodegeneration (N), or ATN. Neurodegeneration will be assessed by atrophy on brain MRI as reflected by regional volumes on Freesurfer. Staff will also evaluate MR neuroimaging markers for neuroinflammation using a newer method called diffusion basis spectrum imaging (DBSI), developed at the Mallinckrodt Institute of Radiology at Washington University in St. Louis in collaboration with The Charles F. and Joanne Knight Alzheimer's Disease Research Center (Knight ADRC).
Key Dates
- Start date
- Oct 18, 2021
- Status verified
- May 2026
- Primary completion
- May 1, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 240 participants (estimated)
Arms
- Arm: metabolically abnormal overweight & obese
- Arm: metabolically normal overweight
- Arm: obese and metabolically normal lean
Primary Outcome Measure
Aim - increased atrophy in MAOO compared to MNOO and MNLP participants [ Time Frame: 10 hours ]
Central Contacts
- Cyrus Raji, MD, PhD314-273-0334
- Nancy Hantler, BS, CCRC, PM314-362-7315
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 |
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