MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease

NCT05402566 | Completed

• 1 other identifier: DMI-AD
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (6)

• Deuterium Metabolic Imaging

  Glucose concentration in whole-brain referenced to baseline scan (sub-study 1).

  Up to 150 mins after 2H-glucose ingestion

• Deuterium Metabolic Imaging

  Lactate concentrations in whole-brain referenced to baseline scan (sub-study 1).

  Up to 150 mins after 2H-glucose ingestion

• Deuterium Metabolic Imaging

  Glx concentrations in whole-brain referenced to baseline scan (sub-study 1).

  Up to 150 mins after 2H-glucose ingestion

• Deuterium Metabolic Imaging

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

  Up to 150 mins after 2H-glucose ingestion

• Deuterium Metabolic Imaging

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

  Up to 150 mins after 2H-glucose ingestion

• Deuterium Metabolic Imaging

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

  Up to 150 mins after 2H-glucose ingestion

Secondary Outcomes (9)

• Deuterium Metabolic Imaging

  Up to 150 mins after 2H-glucose ingestion

• Blood samples

  Up to 150 mins after 2H-glucose ingestion

• Blood samples

  Up to 150 mins after 2H-glucose ingestion

• FDG-PET from the records (sub study 2)

  At time of Deuterium Metabolic Imaging

• Cognitive tests from the records (sub study 2)

  At time of Deuterium Metabolic Imaging

Study Arms (3)

Healhy volunteers

Repeated MRI and DMI for simplification of protocols. Repeated within 6 +/- 2 weeks.

Diagnostic Test: Deuterium metabolic imaging

Alzheimer's disease patients

MRI and DMI to assess cerebral glucose metabolism. Single examination. Compared with PET.

Diagnostic Test: Deuterium metabolic imaging

Healthy controls

MRI and DMI for comparison with AD patients.

Diagnostic Test: Deuterium metabolic imaging

Interventions

Deuterium metabolic imaging DIAGNOSTIC_TEST

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

Alzheimer's disease patients; Healhy volunteers; Healthy controls

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus University

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Bogh 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.

  PMID: 38472611 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 2, 2022
• Study Start: December 22, 2022
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: December 1, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After study is completed.

Locations

DK (1)