Imaging Biomarkers in Alzheimer's Disease - an Exploratory PET Study
Brain imaging study explores blood flow and sugar use in Alzheimer's and diabetes
Plain English Summary
Brain Blood Flow and Sugar Transport in Alzheimer's Disease With and Without Diabetes - A Pilot Imaging Study is a Not Applicable clinical trial sponsored by Rigshospitalet, Denmark studying Alzheimer Dementia (AD), Diabete Type 2. This study uses advanced brain scans (PET) to look at how blood flow and sugar use in the brain are affected in Alzheimer's disease, especially in people who also have type 2 diabetes. It is for individuals with suspected Alzheimer's disease (with or without type 2 diabetes) and healthy older adults. Participation involves brain imaging scans and cognitive tests. The scans are non-invasive and designed to be comfortable. Currently, there are no direct alternatives to this specific type of detailed brain imaging for research purposes, but standard diagnostic methods for Alzheimer's include cognitive tests and other imaging like MRI. The trial aims to enroll 60 participants.
Official 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 dise
Who Can Participate
Here is what you need to know about eligibility for this trial. You may be able to join if you have suspected Alzheimer's disease and are willing to follow the study plan. If you have type 2 diabetes, you may be eligible for a specific group within the study. You cannot join if you have type 2 diabetes and are not in the designated group, have other significant brain diseases (unless you have Alzheimer's), serious vascular or nerve problems, are undergoing cancer treatment, have a history of substance abuse, severe fear of enclosed spaces, or are pregnant or breastfeeding. This trial is studying Alzheimer Dementia (AD), Diabete Type 2, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how efficiently glucose (sugar) is transported from the blood into the brain, which is a key process that may be impaired in Alzheimer's disease and affect thinking abilit The specific primary outcome measures are: Glucose transport (at inclusion). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This pilot study aims to improve understanding of how brain blood flow and sugar handling are altered in Alzheimer's disease, particularly in those with type 2 diabetes, to help identify early changes This research targets Alzheimer Dementia (AD), Diabete Type 2, where improved treatment options are needed.
Investor Insight
This observational pilot study explores novel imaging biomarkers for Alzheimer's disease, a condition with a large and growing market. Identifying early changes related to glucose metabolism and blood
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the scans involve. Participation includes PET scans to measure brain sugar use and blood flow, along with cognitive tests to assess memory and thinking. The study is designed to be safe and comfortable, avoiding invasive procedures. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 60 participants
Interventions
- DIAGNOSTIC_TEST: [18F]FDG PET — Regional glucose metabolism as well as glucose transport will be assessed.
- DIAGNOSTIC_TEST: [11C]PIB — Early perfusion PET after acetazolamide infusion as well as late amyloid load will be assessed.
Primary Outcomes
- Glucose transport (at inclusion)
Secondary Outcomes
- Glucose metabolism (at inclusion)
- Amyloid load (at inclusion)
- Stress perfusion (at inclusion)
Full Eligibility 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
Trial Locations
- Copenhagen University Hospital Herlev, Herlev, Denmark
Frequently Asked Questions
What is clinical trial NCT07482072?
NCT07482072 is a Not Applicable OBSERVATIONAL study titled "Brain Blood Flow and Sugar Transport in Alzheimer's Disease With and Without Diabetes - A Pilot Imaging Study." It is currently recruiting and is sponsored by Rigshospitalet, Denmark. The trial targets enrollment of 60 participants.
What conditions does NCT07482072 study?
This trial investigates treatments for Alzheimer Dementia (AD), Diabete Type 2. The primary condition under study is Alzheimer Dementia (AD).
What treatments are being tested in NCT07482072?
The interventions being studied include: [18F]FDG PET (DIAGNOSTIC_TEST), [11C]PIB (DIAGNOSTIC_TEST). Regional glucose metabolism as well as glucose transport will be assessed.
What does Not Applicable mean for NCT07482072?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07482072?
This trial is currently "Recruiting." It started on 2026-03. The estimated completion date is 2026-12.
Who is sponsoring NCT07482072?
NCT07482072 is sponsored by Rigshospitalet, Denmark. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07482072?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT07482072 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07482072?
The primary outcome measures are: Glucose transport (at inclusion). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07482072 being conducted?
This trial is being conducted at 1 site, including Herlev (Denmark).
Where can I find official information about NCT07482072?
The official record for NCT07482072 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07482072. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07482072 testing in simple terms?
This study uses advanced brain scans (PET) to look at how blood flow and sugar use in the brain are affected in Alzheimer's disease, especially in people who also have type 2 diabetes. It is for individuals with suspected Alzheimer's disease (with or without type 2 diabetes) and healthy older adults.
Why is this trial significant?
This pilot study aims to improve understanding of how brain blood flow and sugar handling are altered in Alzheimer's disease, particularly in those with type 2 diabetes, to help identify early changes
What are the potential risks of participating in NCT07482072?
The main risks are related to the PET scan, which involves a small amount of radiation, similar to other medical imaging procedures. Potential side effects from the tracer injection are generally mild and temporary, such as temporary discomfort or bruising at the injection site. Some individuals might experience mild nausea or headache after the scan. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07482072?
Ask your doctor if this study is right for you and what the scans involve. Participation includes PET scans to measure brain sugar use and blood flow, along with cognitive tests to assess memory and thinking. The study is designed to be safe and comfortable, avoiding invasive procedures. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07482072 signal from an investment perspective?
This observational pilot study explores novel imaging biomarkers for Alzheimer's disease, a condition with a large and growing market. Identifying early changes related to glucose metabolism and blood This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves brain imaging scans and cognitive tests. The scans are non-invasive and designed to be comfortable. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.