MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402566
• Other study ID #: DMI-AD
• Status: Completed
• Start date: December 22, 2022
• Est. completion date: October 27, 2023

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Diagnostic Test:
• Deuterium metabolic imaging
MRI after oral administration of 75g of [6,6'-2H2]glucose.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deuterium Metabolic Imaging	Glucose concentration in whole-brain referenced to baseline scan (sub-study 1).	Up to 150 mins after 2H-glucose ingestion
Primary	Deuterium Metabolic Imaging	Lactate concentrations in whole-brain referenced to baseline scan (sub-study 1).	Up to 150 mins after 2H-glucose ingestion
Primary	Deuterium Metabolic Imaging	Glx concentrations in whole-brain referenced to baseline scan (sub-study 1).	Up to 150 mins after 2H-glucose ingestion
Primary	Deuterium Metabolic Imaging	Lactate/glx ratio in the tempo-parietal cortex (sub-study 2).	Up to 150 mins after 2H-glucose ingestion
Primary	Deuterium Metabolic Imaging	Lactate/glx ratio in the hippocampus (sub-study 2).	Up to 150 mins after 2H-glucose ingestion
Primary	Deuterium Metabolic Imaging	Lactate/glx ratio in the posterior cingulum (sub-study 2).	Up to 150 mins after 2H-glucose ingestion
Secondary	Deuterium Metabolic Imaging	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
Secondary	Blood samples	Glucose	Up to 150 mins after 2H-glucose ingestion
Secondary	Blood samples	2H-enrichment	Up to 150 mins after 2H-glucose ingestion
Secondary	FDG-PET from the records (sub study 2)	Brain glucose uptake	At time of Deuterium Metabolic Imaging
Secondary	Cognitive tests from the records (sub study 2)	The Mini-Mental State Exam (0-30, 30 is best)	At time of Deuterium Metabolic Imaging
Secondary	Cognitive tests from the records (sub study 2)	Addenbrooke's Cognitive Examination (0-100, 100 is best)	At time of Deuterium Metabolic Imaging
Secondary	Cerebrospinal fluid biochemistry from the records (sub study 2)	Total tau protein	At time of Deuterium Metabolic Imaging
Secondary	Cerebrospinal fluid biochemistry from the records (sub study 2)	Phosphorylated tau	At time of Deuterium Metabolic Imaging
Secondary	Cerebrospinal fluid biochemistry from the records (sub study 2)	Amyloid	At time of Deuterium Metabolic Imaging