Alzheimer DiseaseNCT05402566
MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease
An observational study of Alzheimer Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
Diseases of dementia are chronic, untreatable, and cause a massive burden of morbidity. In this proposal, we seek to tackle the problem of better, earlier, and more efficient diagnosis using deuterium metabolic imaging (DMI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Deuterium metabolic imaging
- Type of treatment
- Pill or oral medicine
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Dec 2022to 27 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: In sub-study 1, the population is composed of healthy volunteers. In sub-study 2, patients with Alzheimer's disease and healthy age-matched controls are recruited.
Who may be able to join
- AD-patients:
- Aged 55-85 years.
- Male or female.
- AD diagnosis by the NIA-AA 2011 research criteria.8
- Able to give written informed consent.
- Mini-mental state examination (MMSE) equal to or above 18.9
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- Brain FDG-PET performed at Aarhus University Hospital consistent with AD.
- Healthy participants:
- Aged 18-85 years.
- Male or female.
Who cannot join
- All participants:
- Diabetes or any other metabolic disease.
- Other significant brain disease:
- Strokes.
- Tumors.
- Chronic small vessel disease (clinically suspected, or Fazekas ≥ 2 if clinical MRI is available).
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- Epilepsy.
- Other neurodegenerative or -inflammatory disease.
- Contraindications for MRI:
- Pacemaker, neurostimulator or cochlear implant.
- Metal foreign bodies such as fragments and irremovable piercings.
- Unsafe medical implants (safety of heart valves, hips and the like must be confirmed).
- Claustrophobia.
- Largest circumference including arms > 160 cm.
- Pregnant - women must be post-menopausal or confirmed non-pregnant by an onsite test.
Trial locations and contacts
1 site in 1 country.
About this study
Diseases of dementia are chronic, untreatable, and cause a massive burden of morbidity. In this proposal, we seek to tackle the problem of better, earlier, and more efficient diagnosis using deuterium metabolic imaging (DMI). The study is divided in two sub-studies: 1) optimization and simplification of DMI protocols, and 2) a cross-sectional study of DMI in Alzheimer's patients and healthy controls.
- Conditions
- Alzheimer Disease
- Being tested
- Deuterium metabolic imaging
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuterium metabolic imagingDiagnostic test
MRI after oral administration of 75g of [6,6'-2H2]glucose.
| Study group | Role | What they receive |
|---|---|---|
| Healhy volunteers | Repeated MRI and DMI for simplification of protocols. Repeated within 6 +/- 2 weeks. Receives: Diagnostic Test: Deuterium metabolic imaging | |
| Alzheimer's disease patients | MRI and DMI to assess cerebral glucose metabolism. Single examination. Compared with PET. Receives: Diagnostic Test: Deuterium metabolic imaging | |
| Healthy controls | MRI and DMI for comparison with AD patients. Receives: Diagnostic Test: Deuterium metabolic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deuterium Metabolic Imaging
Glucose concentration in whole-brain referenced to baseline scan (sub-study 1).
Measured: Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Lactate concentrations in whole-brain referenced to baseline scan (sub-study 1).
Measured: Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Glx concentrations in whole-brain referenced to baseline scan (sub-study 1).
Measured: Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Lactate/glx ratio in the tempo-parietal cortex (sub-study 2).
Measured: Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Lactate/glx ratio in the hippocampus (sub-study 2).
Measured: Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Lactate/glx ratio in the posterior cingulum (sub-study 2).
Measured: Up to 150 mins after 2H-glucose ingestion
Secondary outcomes (9)
Deuterium Metabolic Imaging
Simpler DMI quantifications, including reference to external phantoms and internal reference, in the same regions defined in primary outcomes.
Measured: Up to 150 mins after 2H-glucose ingestion
Blood samples
Glucose
Measured: Up to 150 mins after 2H-glucose ingestion
Blood samples
2H-enrichment
Measured: Up to 150 mins after 2H-glucose ingestion
FDG-PET from the records (sub study 2)
Brain glucose uptake
Measured: At time of Deuterium Metabolic Imaging
Cognitive tests from the records (sub study 2)
The Mini-Mental State Exam (0-30, 30 is best)
Measured: At time of Deuterium Metabolic Imaging
Cognitive tests from the records (sub study 2)
Addenbrooke's Cognitive Examination (0-100, 100 is best)
Measured: At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Total tau protein
Measured: At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Phosphorylated tau
Measured: At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Amyloid
Measured: At time of Deuterium Metabolic Imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start22 Dec 2022
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402566
- Sponsor's protocol ID
- DMI-AD
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after study completion and full anonymization.
Publications
Bogh N, Aastrup M, Mortensen JK, Gottrup H, Blicher JU, Borghammer P, Kristensen MH, Hansen ESS, Vaeggemose M, Laustsen C. Comparison of Deuterium Metabolic Imaging with FDG PET in Alzheimer Disease. Radiology. 2025 Apr;315(1):e241808. doi: 10.1148/radiol.241808.
PubMed 40197092Bogh N, Vaeggemose M, Schulte RF, Hansen ESS, Laustsen C. Repeatability of deuterium metabolic imaging of healthy volunteers at 3 T. Eur Radiol Exp. 2024 Mar 13;8(1):44. doi: 10.1186/s41747-024-00426-4.
PubMed 38472611
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05402566
- Acronym / sponsor ID
- DMI-AD
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diseases of dementia are chronic, untreatable, and cause a massive burden of morbidity. In this proposal, we seek to tackle the problem of better, earlier, and more efficient diagnosis using deuterium metabolic imaging (DMI). The study is divided in two sub-studies: 1) optimization and simplification of DMI protocols, and 2) a cross-sectional study of DMI in Alzheimer's patients and healthy controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healhy volunteers | – | Diagnostic Test: Deuterium metabolic imagingRepeated MRI and DMI for simplification of protocols. Repeated within 6 +/- 2 weeks. |
| Alzheimer's disease patients | – | Diagnostic Test: Deuterium metabolic imagingMRI and DMI to assess cerebral glucose metabolism. Single examination. Compared with PET. |
| Healthy controls | – | Diagnostic Test: Deuterium metabolic imagingMRI and DMI for comparison with AD patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- In sub-study 1, the population is composed of healthy volunteers. In sub-study 2, patients with Alzheimer's disease and healthy age-matched controls are recruited.
Key inclusion criteria (10 listed)
- Aged 55-85 years.
- Male or female.
- AD diagnosis by the NIA-AA 2011 research criteria.8
- Able to give written informed consent.
- Mini-mental state examination (MMSE) equal to or above 18.9
Key exclusion criteria (15 listed)
- Diabetes or any other metabolic disease.
- Other significant brain disease:
- Contraindications for MRI:
- Pregnant - women must be post-menopausal or confirmed non-pregnant by an onsite test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deuterium metabolic imagingMRI after oral administration of 75g of [6,6'-2H2]glucose. | Diagnostic test | Alzheimer's disease patients, Healhy volunteers, Healthy controls |
Primary outcome
Deuterium Metabolic Imaging
Time frame: Up to 150 mins after 2H-glucose ingestion
Glucose concentration in whole-brain referenced to baseline scan (sub-study 1).
Deuterium Metabolic Imaging
Time frame: Up to 150 mins after 2H-glucose ingestion
Lactate concentrations in whole-brain referenced to baseline scan (sub-study 1).
Deuterium Metabolic Imaging
Time frame: Up to 150 mins after 2H-glucose ingestion
Glx concentrations in whole-brain referenced to baseline scan (sub-study 1).
Deuterium Metabolic Imaging
Time frame: Up to 150 mins after 2H-glucose ingestion
Lactate/glx ratio in the tempo-parietal cortex (sub-study 2).
Deuterium Metabolic Imaging
Time frame: Up to 150 mins after 2H-glucose ingestion
Lactate/glx ratio in the hippocampus (sub-study 2).
Deuterium Metabolic Imaging
Time frame: Up to 150 mins after 2H-glucose ingestion
Lactate/glx ratio in the posterior cingulum (sub-study 2).
9 secondary outcomes
Deuterium Metabolic Imaging
Time frame: Up to 150 mins after 2H-glucose ingestion
Blood samples
Time frame: Up to 150 mins after 2H-glucose ingestion
Blood samples
Time frame: Up to 150 mins after 2H-glucose ingestion
FDG-PET from the records (sub study 2)
Time frame: At time of Deuterium Metabolic Imaging
Cognitive tests from the records (sub study 2)
Time frame: At time of Deuterium Metabolic Imaging
Cognitive tests from the records (sub study 2)
Time frame: At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Time frame: At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Time frame: At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Time frame: At time of Deuterium Metabolic Imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 40197092Bogh N, Aastrup M, Mortensen JK, Gottrup H, Blicher JU, Borghammer P, Kristensen MH, Hansen ESS, Vaeggemose M, Laustsen C. Comparison of Deuterium Metabolic Imaging with FDG PET in Alzheimer Disease. Radiology. 2025 Apr;315(1):e241808. doi: 10.1148/radiol.241808.
- Derived from this study: PubMed 38472611Bogh N, Vaeggemose M, Schulte RF, Hansen ESS, Laustsen C. Repeatability of deuterium metabolic imaging of healthy volunteers at 3 T. Eur Radiol Exp. 2024 Mar 13;8(1):44. doi: 10.1186/s41747-024-00426-4.
- Individual participant dataSharing planned: Yes. Data will be shared after study completion and full anonymization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deuterium Metabolic Imaging (time frame: Up to 150 mins after 2H-glucose ingestion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.