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Completed

NCT Number: NCT05402566

MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University

Aarhus, 8200, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Deuterium metabolic imaging

Diagnostic Test

MRI after oral administration of 75g of [6,6'-2H2]glucose.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. Deuterium Metabolic Imaging

    Time frame: Up to 150 mins after 2H-glucose ingestion

    Lactate/glx ratio in the tempo-parietal cortex (sub-study 2).

  5. Deuterium Metabolic Imaging

    Time frame: Up to 150 mins after 2H-glucose ingestion

    Lactate/glx ratio in the hippocampus (sub-study 2).

  6. Deuterium Metabolic Imaging

    Time frame: Up to 150 mins after 2H-glucose ingestion

    Lactate/glx ratio in the posterior cingulum (sub-study 2).

Secondary outcomes

  1. 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.

  2. Blood samples

    Time frame: Up to 150 mins after 2H-glucose ingestion

    Glucose

  3. Blood samples

    Time frame: Up to 150 mins after 2H-glucose ingestion

    2H-enrichment

  4. FDG-PET from the records (sub study 2)

    Time frame: At time of Deuterium Metabolic Imaging

    Brain glucose uptake

  5. 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)

  6. 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)

  7. Cerebrospinal fluid biochemistry from the records (sub study 2)

    Time frame: At time of Deuterium Metabolic Imaging

    Total tau protein

  8. Cerebrospinal fluid biochemistry from the records (sub study 2)

    Time frame: At time of Deuterium Metabolic Imaging

    Phosphorylated tau

  9. Cerebrospinal fluid biochemistry from the records (sub study 2)

    Time frame: At time of Deuterium Metabolic Imaging

    Amyloid

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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