Brain blood flow and sugar transport in Alzheimer's with and without type 2 diabetes
Imaging Biomarkers in Alzheimer's Disease - an Exploratory PET Study
This project will try to see if patterns of brain blood flow and sugar use differ between people with Alzheimer's disease who do and do not have type 2 diabetes and compared with healthy older adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Herlev) |
| Trial ID | NCT07482072 on ClinicalTrials.gov |
What this trial studies
This is a comparative imaging pilot enrolling 60 participants split into three groups: suspected Alzheimer's without diabetes, suspected Alzheimer's with type 2 diabetes, and healthy age-matched controls (20 per group). Participants will undergo dynamic [11C]PiB PET after acetazolamide to capture early perfusion signals and late-phase β-amyloid load, dynamic [18F]FDG PET with a prebolus and heart scans to measure glucose transport and cerebral metabolic rate of glucose, plus MRI (if not available within five years) and neuropsychological testing. The primary outcome is the volume and overlap of abnormal regions across the imaging biomarkers with diabetes status considered, and secondary outcomes include correlations between a cognitive index score and biomarker volumes. The design aims to identify whether diabetes changes the spatial pattern or severity of perfusion, amyloid, and glucose-metabolism abnormalities in Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates are older adults with suspected Alzheimer's disease either with or without type 2 diabetes, and healthy age-matched volunteers, who can undergo PET and MRI imaging and cognitive testing.
Not a fit: People receiving active cancer treatment, with severe claustrophobia, pregnant or breastfeeding, with recent substance abuse, or with major brain disease other than dementia are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help identify imaging patterns that signal different disease mechanisms in people with Alzheimer's and diabetes, potentially guiding earlier detection or more tailored management.
How similar studies have performed: Previous PET and MRI studies have shown altered amyloid deposition, perfusion, and glucose metabolism in Alzheimer's disease and in diabetes separately, but the specific combination of acetazolamide-challenged PiB and dynamic FDG to compare diabetic versus non-diabetic Alzheimer's is relatively novel and mostly explored in small pilot work.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * suspected Alzheimer's disease * type 2 diabetes (group A) * able and willing to comply with study protocoil´´l Exclusion Criteria: * type 2 diabetes (group B and C) * significant brain disease apart from dementia (group A and B) * significant vascular or neurological disease (group C) * active cancer treatment * history of alcohol or drug abuse * severe claustrophobia * pregnancy or breastfeeding
Where this trial is running
Herlev
- Copenhagen University Hospital Herlev — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Lisbeth Marner, MD, DMSc, PhD
- Email: Lisbeth.marner@regionh.dk
- Phone: +4538682041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.