MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease

NCT ID: NCT05402566

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healhy volunteers

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

Deuterium metabolic imaging

Intervention Type DIAGNOSTIC_TEST

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.

Deuterium metabolic imaging

Intervention Type DIAGNOSTIC_TEST

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

Healthy controls

MRI and DMI for comparison with AD patients.

Deuterium metabolic imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Deuterium metabolic imaging

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aarhus University

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 38472611 (View on PubMed)

Other Identifiers

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DMI-AD

Identifier Type: -

Identifier Source: org_study_id