RECRUITING

Alzheimer"s Imaging Biomarkers in Obesity

Conditions

Alzheimer Disease Obesity Metabolic Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife Obesity

Quick Facts

Study Start:2021-10-18

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05077579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Male and female, 40-60 years of age and any race; 2. MMSE = or greater than 25 or a Clinical Dementia Rating Scale (CDR)=0; 3. Willing and able to undergo MRI 4. Willing to complete PET scans, including \[11C\]PiB and 18F-AV-1451 (Flortaucipir) radioactive tracer injection under protocols IRB #201409014 \& 201906028 5. Willing to participate in the metabolic subtyping of metabolically normal or abnormal overweight or obese status for the following three groups:	1. 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); 2. Intend to have bariatric surgery; 3. Inability to tolerate to lie still during the scanning procedures (e.g., severe, chronic back pain); 4. Severe claustrophobia; 5. Women who are currently pregnant or breast-feeding; 6. Currently receiving an active obesity study drug (or placebo) or in an obesity clinical trial; 7. Laboratory Evaluations exclusion: • Oral glucose tolerance test should not be performed in patients who already fulfill the criteria for diabetes mellitus. These include: - History of Type 1 or 2 diabetes mellitus - Prior documentation of a fasting plasma glucose \>7.0 mmol/L or two or more occasions or clinical symptoms of diabetes e.g. polydipsia, polyuria, ketonuria and rapid weight loss with a random plasma glucose of \>11.1 mmol/L • Other contraindications for venous access as part of OGTT or blood draws: - Venous fibrosis or shunt grafts in both upper extremities - Ongoing cellulitis or infection, particularly in the upper extremities. - Presence of a hematoma at the site of vascular access. - History of hypoglycemic encephalopathy that can occur with prolonged fasting 8. MRI exclusion: • Contraindications to MRI (e.g., certain incompatible electronic medical devices that make it potentially unsafe for the individual to participate). All participants must be willing to undergo at least two MRI screenings, supervised by Level II MRI personnel as designated by the American College of Radiology (ACR).

Inclusion Criteria

Exclusion Criteria

1. Male and female, 40-60 years of age and any race;
2. MMSE = or greater than 25 or a Clinical Dementia Rating Scale (CDR)=0;
3. Willing and able to undergo MRI
4. Willing to complete PET scans, including \[11C\]PiB and 18F-AV-1451 (Flortaucipir) radioactive tracer injection under protocols IRB #201409014 \& 201906028
5. Willing to participate in the metabolic subtyping of metabolically normal or abnormal overweight or obese status for the following three groups:

1. 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);
2. Intend to have bariatric surgery;
3. Inability to tolerate to lie still during the scanning procedures (e.g., severe, chronic back pain);
4. Severe claustrophobia;
5. Women who are currently pregnant or breast-feeding;
6. Currently receiving an active obesity study drug (or placebo) or in an obesity clinical trial;
7. Laboratory Evaluations exclusion: • Oral glucose tolerance test should not be performed in patients who already fulfill the criteria for diabetes mellitus. These include: - History of Type 1 or 2 diabetes mellitus - Prior documentation of a fasting plasma glucose \>7.0 mmol/L or two or more occasions or clinical symptoms of diabetes e.g. polydipsia, polyuria, ketonuria and rapid weight loss with a random plasma glucose of \>11.1 mmol/L • Other contraindications for venous access as part of OGTT or blood draws: - Venous fibrosis or shunt grafts in both upper extremities - Ongoing cellulitis or infection, particularly in the upper extremities. - Presence of a hematoma at the site of vascular access. - History of hypoglycemic encephalopathy that can occur with prolonged fasting
8. MRI exclusion: • Contraindications to MRI (e.g., certain incompatible electronic medical devices that make it potentially unsafe for the individual to participate). All participants must be willing to undergo at least two MRI screenings, supervised by Level II MRI personnel as designated by the American College of Radiology (ACR).

Contacts and Locations

Study Contact

Cyrus Raji, MD, PhD

CONTACT

314-273-0334

craji@wustl.edu

Nancy Hantler, BS, CCRC, PM

CONTACT

314-362-7315

hantlern@wustl.edu

Principal Investigator

Cyrus Raji, MD, PhD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Cyrus A Raji

Cyrus Raji, MD, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-18

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-10-18

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease
Obesity
Metabolic Disease