Taking people in United StatesNo phase

Brain Imaging Study of Alzheimer's Markers in Midlife Obesity

Compares brain scan markers for Alzheimer's disease in adults aged 40 to 60 with obesity.

Key facts

Who runs it: Cyrus A Raji
Where: St Louis, United StatesSee the site
Trial code: NCT05077579
Registry title: Alzheimer"s Imaging Biomarkers in Obesity
Status: Recruiting
People taking part: 240 people, planned
Started: 18 Oct 2021
Expected to end: 31 Dec 2027
Type of study: Observational, 3 groups
Record updated: 11 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men and women aged 40 to 60 with normal thinking and memory. Some are overweight or obese, and some are lean. They will have brain scans.

Age: 40 to 60 years
Sex: Men and women
Disease stage: Normal thinking and memory (MMSE 25 or higher, or CDR 0). Body weight in three groups by BMI and blood sugar and insulin tests: overweight or obese with abnormal tests, overweight or obese with normal tests, lean with normal tests.
Earlier treatment: Cannot be taking a drug for obesity now or be in an obesity clinical trial.
Biomarker or test result: Blood sugar, insulin and HbA1c results decide the group. Overweight or obese groups need a BMI of 25 or more but under 45. The lean group needs a BMI of 18.5 or more but under 25.

Main reasons for not taking part

Plans to have bariatric surgery
Currently pregnant or breast-feeding
Diabetes, or any reason an oral glucose tolerance test cannot be done
Severe claustrophobia or cannot lie still during scans
Anything that makes MRI unsafe, such as some electronic medical devices

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

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:; 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; 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; 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

Who cannot take part

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
Currently receiving an active obesity study drug (or placebo) or in an obesity clinical trial
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
Inability to tolerate to lie still during the scanning procedures (e.g., severe, chronic back pain)
Severe claustrophobia
Women who are currently pregnant or breast-feeding
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)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 40 and 60 years old?

Where in United States

Washington University School of MedicineSt Louis, United StatesContact: LaKisha A Lloyd, MSTaking people

About the trial

What the trial wants to find out

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).