Clinical trial NCT05402566: MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease
Official title: MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2022-06-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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). 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Deuterium Metabolic Imaging
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: Deuterium Metabolic Imaging
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: Deuterium Metabolic Imaging
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: Deuterium Metabolic Imaging
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: Deuterium Metabolic Imaging
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: Deuterium Metabolic Imaging
timeFrame: Up to 150 mins after 2H-glucose ingestion
Secondary outcomes:
measure: Deuterium Metabolic Imaging
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: Blood samples
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: Blood samples
timeFrame: Up to 150 mins after 2H-glucose ingestion
measure: FDG-PET from the records (sub study 2)
timeFrame: At time of Deuterium Metabolic Imaging
measure: Cognitive tests from the records (sub study 2)
timeFrame: At time of Deuterium Metabolic Imaging
measure: Cognitive tests from the records (sub study 2)
timeFrame: At time of Deuterium Metabolic Imaging
measure: Cerebrospinal fluid biochemistry from the records (sub study 2)
timeFrame: At time of Deuterium Metabolic Imaging
measure: Cerebrospinal fluid biochemistry from the records (sub study 2)
timeFrame: At time of Deuterium Metabolic Imaging
measure: Cerebrospinal fluid biochemistry from the records (sub study 2)
timeFrame: At time of Deuterium Metabolic Imaging
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
References: