Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife Obesity

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 60
Healthy Volunteers: t
View:

• Male and female, 40-60 years of age and any race;

• MMSE = or greater than 25 or a Clinical Dementia Rating Scale (CDR)=0;

• Willing and able to undergo MRI

• Willing to complete PET scans, including \[11C\]PiB and 18F-AV-1451 (Flortaucipir) radioactive tracer injection under protocols IRB #201409014 \& 201906028

• Willing to participate in the metabolic subtyping of metabolically normal or abnormal overweight or obese status for the following three groups:

• a. Group 1: MAOO criteria: i. BMI ≥25 but \<45 kg/m2; ii. Maximum body circumference \< 165 cm to ensure participants fit into the PET/CT and MR scanners; iii. Fasting blood glucose: ≥100 mg/dl or blood glucose 2 h after an OGTT: ≥140 or fasting insulin: \>20 µu/ml;

• b. Group 2: MNOO criteria: i. BMI ≥ 25 but \<45 kg/m2; ii. Maximum body circumference \< 165 cm to ensure participants fit into the PET/CT and MR scanners; iii. Blood glucose 2 h after an OGTT: iv. HbA1c \< 5.7% v. Fasting insulin: \< 20 µu/ml;

• c. Group 3: MNLP criteria: i. BMI ≥18.5 but \< 25.0 kg/m2; ii. Maximum body circumference \< 165 cm to ensure subjects fit into the PET/CT and MR scanners; iii. Fasting blood glucose: \< 100 mg/dl; iv. Blood glucose 2 h after an OGTT: \< 140 mg/dl; v. HbA1c \< 5.7% vi. Fasting insulin: \< 20 µu/ml;

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Cyrus Raji, MD, PhD
craji@wustl.edu
314-273-0334
Backup
Nancy Hantler, BS, CCRC, PM
hantlern@wustl.edu
314-362-7315
Time Frame
Start Date: 2021-10-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 240
Treatments
metabolically abnormal overweight & obese
metabolically normal overweight
obese and metabolically normal lean
Related Therapeutic Areas
Sponsors
Leads: Cyrus A Raji

This content was sourced from clinicaltrials.gov