Brain Blood Flow and Sugar Transport in Alzheimer's Disease With and Without Diabetes - A Pilot Imaging Study

NCT07482072 | Recruiting

• 1 other identifier: H-25047865
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's disease is the most common cause of dementia and affects a growing number of older adults. Although harmful proteins build up in the brain, we still do not fully understand why some brain regions are affected earlier or more severely than others. Many people with Alzheimer's disease also have problems with blood flow and sugar handling in the brain, and these changes may play an important role in disease development. People with type 2 diabetes are at especially high risk of developing Alzheimer's disease and often experience a more severe disease course. This pilot study aims to improve our understanding of how brain blood flow and sugar use are altered in Alzheimer's disease, and whether these changes differ in people with and without type 2 diabetes. We will study three groups: people with Alzheimer's disease without diabetes, people with Alzheimer's disease and type 2 diabetes, and healthy older individuals. By comparing these groups, we aim to identify early brain changes that may contribute to cognitive decline. Participants will undergo advanced brain imaging using positron emission tomography (PET) scans. One scan uses a radioactive sugar tracer to measure how the brain takes up and uses glucose. Importantly, a new non-invasive method will also allow us to estimate how efficiently glucose is transported from the blood into the brain. This is a key process that may be impaired in Alzheimer's disease, but has previously required invasive procedures. The new approach avoids arterial cannulation, making the study safer and more comfortable for participants. A second PET scan will assess brain blood flow and blood vessel function, including how well the vessels can respond to increased demand. Participants will also complete cognitive tests to assess memory and thinking abilities. Ultimately, this research may contribute to earlier diagnosis, better monitoring of disease progression, and development of new treatment strategies for Alzheimer's disease.

Conditions

Alzheimer Dementia (AD); Diabete Type 2

Keywords

neuroimaging; Alzheimer's disease; amyloid; glucose transport; glucose metabolism

Outcome Measures

Primary Outcomes (1)

• Glucose transport

  Regional flux of glucose to brain regions, (mmol/mL/min )

  at inclusion

Secondary Outcomes (3)

• Glucose metabolism

  at inclusion

• Amyloid load

  at inclusion

• Stress perfusion

  at inclusion

Study Arms (3)

Alzheimer's disease with type 2 diabetes

Suspected Alzheimer's disease combined with type 2 diabetes

Diagnostic Test: [18F]FDG PET; Diagnostic Test: [11C]PIB

Alzheimer's disease without type 2 diabetes

Suspected Alzheimer's disease. No diagnosis of type 2 diabetes

Diagnostic Test: [18F]FDG PET; Diagnostic Test: [11C]PIB

Healthy subjects

Age-matched subjects with no major vascular or neuroological diseses

Diagnostic Test: [18F]FDG PET; Diagnostic Test: [11C]PIB

Interventions

[18F]FDG PET DIAGNOSTIC_TEST

Regional glucose metabolism as well as glucose transport will be assessed.

Alzheimer's disease with type 2 diabetes; Alzheimer's disease without type 2 diabetes; Healthy subjects

[11C]PIB DIAGNOSTIC_TEST

Early perfusion PET after acetazolamide infusion as well as late amyloid load will be assessed.

Alzheimer's disease with type 2 diabetes; Alzheimer's disease without type 2 diabetes; Healthy subjects

Eligibility Criteria

• Age: 60 Years - 90 Years
• Gender Eligibility Details: Healthy subjects have to be gender matched to the patients.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited from the memory clinica at Herlev Hospital, Copenhagen, Denmark

You may qualify if:

• suspected Alzheimer's disease
• type 2 diabetes (group A)
• able and willing to comply with study protocoil´´l

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

Copenhagen University Hospital Herlev

Herlev, 2730, Denmark

RECRUITING

Related Publications (2)

• Gejl M, Brock B, Egefjord L, Vang K, Rungby J, Gjedde A. Blood-Brain Glucose Transfer in Alzheimer's disease: Effect of GLP-1 Analog Treatment. Sci Rep. 2017 Dec 13;7(1):17490. doi: 10.1038/s41598-017-17718-y.

  PMID: 29235507 BACKGROUND

• Bach MJ, Larsen ME, Kellberg AO, Henriksen AC, Fuglsang S, Rasmussen IL, Lonsdale MN, Lubberink M, Marner L. Non-invasive [15O]H2O PET measurements of cerebral perfusion and cerebrovascular reactivity using an additional heart scan. J Cereb Blood Flow Metab. 2025 Jun;45(6):1144-1152. doi: 10.1177/0271678X251313743. Epub 2025 Jan 20.

  PMID: 39829334 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Lisbeth Marner, MD, DMSc, PhD

CONTACT

+4538682041; Lisbeth.marner@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 19, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

DK (1)