MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease

November 30, 2023 updated by: University of Aarhus
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion criteria:

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
  • Brain FDG-PET performed at Aarhus University Hospital consistent with AD.

Healthy participants:

  • Aged 18-85 years.
  • Male or female.

Exclusion criteria:

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).
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healhy volunteers
Repeated MRI and DMI for simplification of protocols. Repeated within 6 +/- 2 weeks.
Diagnostic test: Deuterium metabolic imaging
MRI after oral administration of 75g of [6,6'-2H2]glucose.
Alzheimer's disease patients
MRI and DMI to assess cerebral glucose metabolism. Single examination. Compared with PET.
Diagnostic test: Deuterium metabolic imaging
MRI after oral administration of 75g of [6,6'-2H2]glucose.
Healthy controls
MRI and DMI for comparison with AD patients.
Diagnostic test: Deuterium metabolic imaging
MRI after oral administration of 75g of [6,6'-2H2]glucose.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to 150 mins after 2H-glucose ingestion
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).
Up to 150 mins after 2H-glucose ingestion
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).
Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Time Frame: Up to 150 mins after 2H-glucose ingestion
Lactate/glx ratio in the tempo-parietal cortex (sub-study 2).
Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Time Frame: Up to 150 mins after 2H-glucose ingestion
Lactate/glx ratio in the hippocampus (sub-study 2).
Up to 150 mins after 2H-glucose ingestion
Deuterium Metabolic Imaging
Time Frame: Up to 150 mins after 2H-glucose ingestion
Lactate/glx ratio in the posterior cingulum (sub-study 2).
Up to 150 mins after 2H-glucose ingestion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Deuterium Metabolic Imaging
Time Frame: Up to 150 mins after 2H-glucose ingestion
Simpler DMI quantifications, including reference to external phantoms and internal reference, in the same regions defined in primary outcomes.
Up to 150 mins after 2H-glucose ingestion
Blood samples
Time Frame: Up to 150 mins after 2H-glucose ingestion
Glucose
Up to 150 mins after 2H-glucose ingestion
Blood samples
Time Frame: Up to 150 mins after 2H-glucose ingestion
2H-enrichment
Up to 150 mins after 2H-glucose ingestion
FDG-PET from the records (sub study 2)
Time Frame: At time of Deuterium Metabolic Imaging
Brain glucose uptake
At time of Deuterium Metabolic Imaging
Cognitive tests from the records (sub study 2)
Time Frame: At time of Deuterium Metabolic Imaging
The Mini-Mental State Exam (0-30, 30 is best)
At time of Deuterium Metabolic Imaging
Cognitive tests from the records (sub study 2)
Time Frame: At time of Deuterium Metabolic Imaging
Addenbrooke's Cognitive Examination (0-100, 100 is best)
At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Time Frame: At time of Deuterium Metabolic Imaging
Total tau protein
At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Time Frame: At time of Deuterium Metabolic Imaging
Phosphorylated tau
At time of Deuterium Metabolic Imaging
Cerebrospinal fluid biochemistry from the records (sub study 2)
Time Frame: At time of Deuterium Metabolic Imaging
Amyloid
At time of Deuterium Metabolic Imaging

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMI-AD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared after study completion and full anonymization.

IPD Sharing Time Frame

After study is completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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