Alzheimer"s Imaging Biomarkers in Obesity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-60
SponsorCyrus A Raji

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Any condition that in the opinion of the Investigator or designee could increase the risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection of the data, (e.g., currently taking a drug for treatment of obesity);

Intend to have bariatric surgery;

Inability to tolerate to lie still during the scanning procedures (e.g., severe, chronic back pain);

Severe claustrophobia;

Trial population

We currently have IRB-approved protocols covering ongoing imaging that meet the eligibility criteria. The Washington University Knight Alzheimer's Disease Research Center and the Center for Human Nutrition will refer participants . The Knight ADRC primarily recruits participants by means of word of mouth and public service announcements from the greater metropolitan St. Louis area. We will also coordinate these efforts with the Center for Human Nutrition to maximize potential participants from their studies. A small percentage (\~17%) of participants are referred by Washington University physicians. The Research Participant Registry/Volunteer for Health (VFH) Program at Washington University in St. Louis (https://vfh.wustl.edu) will also be utilized.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

240 Participants
are grouped into 3 trial groups
Group A: metabolically abnormal overweight & obese
Group B: metabolically normal overweight
Group C: obese and metabolically normal lean

Trial outcomes

Primary outcomes

1

Aim - increased atrophy in MAOO compared to MNOO and MNLP participants

we hypothesize increased atrophy in MAOO compared to MNOO and MNLP particularly in regions important for AD pathology such as the hippocampus and hippocampal sub-regions. These will be measured through the results of the blood tests, MRI scan \& data from the PET scans.

Time frame
10 hours

Secondary outcomes

1

Aim 2- higher burden of white matter neuroinflammation on DBSI

We hypothesize a higher burden of white matter neuroinflammation on DBSI in MAOO in relation to other overweight and obese groups. The MRI scan will be used to measure these outcomes.

Time frame
10 hours
2

Aim 3-increased amyloid and tau deposition on brain

We hypothesize increased amyloid and tau deposition on brain PET in MAOO versus other groups. The PET scan data will be used to measure these outcomes.

Time frame
10 hours

Other outcomes

1

Sub-aims-sex differences in atrophy and neuroinflammation

Will examine sex differences in atrophy and neuroinflammation. We will also investigate sex differences in amyloid and tau deposition across the overweight/obese and lean groups. These will be measured through the results of the blood tests, MRI scan \& data from the PET scans.

Time frame
10 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cyrus A Raji

Lead sponsor

Washington University School of Medicine

Sponsor institution