Actively Recruiting

Age: 40Years - 60Years
All Genders
Healthy Volunteers
NCT05077579

Alzheimer"s Imaging Biomarkers in Obesity

Led by Cyrus A Raji · Updated on 2026-05-11

240

Participants Needed

1

Research Sites

323 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Alzheimer"s Imaging Biomarkers in Obesity

Who Can Participate

Age: 40Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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 (CDR) equal to 0
  • Willing and able to undergo MRI
  • Willing to complete PET scans including radioactive tracer injections
  • Willing to participate in metabolic subtyping for overweight or obese status in one of three groups: MAOO, MNOO, or MNLP
  • MAOO group: BMI 25 to less than 45 kg/m2; maximum body circumference less than 165 cm; fasting blood glucose 100 mg/dl or higher or blood glucose 2 hours after OGTT 140 mg/dl or higher or fasting insulin over 20 µu/ml
  • MNOO group: BMI 25 to less than 45 kg/m2; maximum body circumference less than 165 cm; blood glucose 2 hours after OGTT less than 140 mg/dl; HbA1c less than 5.7%; fasting insulin less than 20 µu/ml
  • MNLP group: BMI 18.5 to less than 25 kg/m2; maximum body circumference less than 165 cm; fasting blood glucose less than 100 mg/dl; blood glucose 2 hours after OGTT less than 140 mg/dl; HbA1c less than 5.7%; fasting insulin less than 20 µu/ml
Not Eligible

You will not qualify if you...

  • Any condition that may increase risk or interfere with study procedures, such as current use of obesity treatment drugs
  • Intention to have bariatric surgery
  • Inability to lie still during scanning procedures
  • Severe claustrophobia
  • Women who are pregnant or breastfeeding
  • Currently receiving an active obesity study drug or participating in an obesity clinical trial
  • Diabetes mellitus as defined by history or clinical symptoms or fasting plasma glucose over 7.0 mmol/L or random plasma glucose over 11.1 mmol/L
  • Contraindications to oral glucose tolerance test or blood draws, including venous fibrosis, shunt grafts, infections, hematoma, or history of hypoglycemic encephalopathy
  • Contraindications to MRI such as incompatible electronic medical devices
  • Must be willing to undergo at least two MRI screenings supervised by qualified personnel

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

Loading map...

Research Team

C

Cyrus Raji, MD, PhD

CONTACT

N

Nancy Hantler, BS, CCRC, PM

CONTACT

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here