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Alzheimer"s Imaging Biomarkers in Obesity

Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife Obesity

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 60 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Neurodegeneration will be assessed by atrophy on brain MRI as reflected by regional volumes on Freesurfer."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how body fat and blood sugar health may be linked to early signs of Alzheimer's disease in the brain. It is for adults ages 40–60 with normal memory and thinking, including people with lean bodies, overweight, or obesity. Participants will have blood sugar tests and brain scans.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults ages 40–60, of any sex or race.
  • A score of at least 25 on the MMSE memory and thinking test, or 0 on the Clinical Dementia Rating scale.
  • Willing and able to have MRI brain scans.
  • Willing to have PET brain scans with injections of radioactive tracers that help show changes in the brain.
  • Willing to have tests of how the body handles sugar. Must fit one of the three groups below and measure less than 165 cm around the widest part of the body to fit the scanners.
  • Overweight or obesity with abnormal test results: BMI from 25 to under 45, plus fasting blood sugar of at least 100 mg/dL, blood sugar of at least 140 mg/dL two hours after a sugar drink, or fasting insulin above 20 µu/mL. BMI is a measure based on height and weight.
  • Overweight or obesity with normal test results: BMI from 25 to under 45, A1c below 5.7%, and fasting insulin below 20 µu/mL. A1c measures average blood sugar. The listing does not give the required blood sugar level after a sugar drink for this group.
  • Lean group: BMI from 18.5 to under 25, fasting blood sugar below 100 mg/dL, blood sugar below 140 mg/dL two hours after a sugar drink, A1c below 5.7%, and fasting insulin below 20 µu/mL.

Who can't join

  • A condition or treatment that the study doctor thinks could make the study unsafe or affect the tests, such as taking medicine for obesity.
  • Planning weight-loss surgery.
  • Unable to lie still for scans, or very afraid of small, closed spaces.
  • Currently pregnant or breastfeeding.
  • Taking part in an obesity trial, or receiving an obesity study drug or placebo—a treatment with no active drug.
  • Already meeting the criteria for diabetes, including a history of type 1 or type 2 diabetes, prevents the sugar drink test.
  • Problems that make blood draws or the sugar drink test unsafe, such as scarred veins or blood-vessel grafts in both arms, an ongoing skin infection, a bruise where blood would be drawn, or past brain problems caused by low blood sugar during a long fast.
  • Unable to safely have MRI scans, such as having certain medical devices that are not MRI-safe. Participants must agree to at least two MRI safety checks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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: 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; Exclusion Criteria: 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).

Study sites (1)

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