Actively Recruiting
Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife Obesity
Led by Cyrus A Raji · Updated on 2026-05-11
240
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how high body fat in middle-aged adults, shown by overweight or obesity, might increase the risk of Alzheimer's disease. The study focuses on adults aged 40 to 60 who are cognitively normal. Participants will be grouped based on metabolic health using tests like oral glucose tolerance, fasting insulin, glucose, and hemoglobin A1c, to classify them as metabolically abnormal overweight or obese (MAOO), metabolically normal overweight or obese (MNOO), or metabolically normal lean participants (MNLP). The study aims to understand differences in brain changes related to Alzheimer's biomarkers, including amyloid, tau, and neurodegeneration. Participants will undergo metabolic testing and advanced brain imaging techniques. Neurodegeneration will be assessed using brain MRI to measure regional brain volume loss. Researchers will also use a specialized imaging method called diffusion basis spectrum imaging (DBSI) to evaluate neuroinflammation in the brain. Additional brain scans include PET scans using specific radioactive tracers to detect amyloid and tau deposits. The study groups are based on body mass index, body circumference, and metabolic markers to observe how these factors relate to Alzheimer's changes. During the study, participants will complete metabolic tests, brain MRIs, and PET scans. The research team will measure brain atrophy, neuroinflammation, and amyloid and tau buildup to compare among the different metabolic groups. Participants must be able to undergo these imaging procedures and complete cognitive assessments like the MMSE or Clinical Dementia Rating Scale. The total time for outcome measurements is about 10 hours. The study will continue through 2027, monitoring participants to gain insights into the links between midlife obesity, metabolism, and Alzheimer's disease biomarkers.
CONDITIONS
Brief Title
Alzheimer"s Imaging Biomarkers in Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female, 40-60 years of age and any race
- MMSE score of 25 or higher or Clinical Dementia Rating Scale of 0
- Willing and able to undergo MRI
- Willing to complete PET scans with specific radioactive tracers
- Willing to participate in metabolic subtyping as metabolically abnormal overweight/obese, metabolically normal overweight/obese, or metabolically normal lean based on BMI, body circumference, glucose, insulin, and HbA1c measurements
- BMI between 18.5 and less than 45 kg/m2
- Maximum body circumference less than 165 cm to fit imaging scanners
- Specific metabolic criteria for each group regarding fasting glucose, glucose after oral glucose tolerance test, HbA1c, and fasting insulin
You will not qualify if you...
- Any condition increasing risk or limiting ability to tolerate procedures (e.g., current obesity treatment drug use)
- Planned bariatric surgery
- Inability to lie still during scans (e.g., severe chronic back pain)
- Severe claustrophobia
- Women who are pregnant or breastfeeding
- Currently receiving an active obesity study drug or participating in an obesity clinical trial
- Diagnosis of diabetes mellitus or related clinical symptoms
- Contraindications to venous access for blood tests (e.g., venous fibrosis, infection, hematoma)
- History of hypoglycemic encephalopathy
- Contraindications to MRI or incompatible medical devices
- Inability or unwillingness to undergo at least two MRI screenings supervised by designated personnel
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits for eligibility assessments including metabolic and cognitive testing
Duration - 1 day
Participants undergo imaging and metabolic assessments to evaluate brain biomarkers and metabolic status.
1 visit including MRI and PET scans and metabolic measurements
Duration - Up to 5 years
Participants are observed over time to monitor brain changes and metabolic outcomes without receiving active treatment.
Follow-up visits scheduled as needed for repeat assessments
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
C
Cyrus Raji, MD, PhD
N
Nancy Hantler, BS, CCRC, PM
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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