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Visualising Cerebral and Peripheral Cholinergic Nerves in Patients With Dementia Lewy Bodies.

NCT04291144 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-05-22

No results posted yet for this study

Summary

Lewy Body Dementia (DLB) is the second most common type of neurodegenerative dementia and characterized by loss of cholinergic neurons in the cerebrum and possibly also internal organs. A novel tracer, 18F-fluoroethoxybenzovesamicol (18F-FEOBV), binds to the cholinergic vesicle transporter, a protein expressed uniquely in the vesicles of cholinergic pre-synapses. Our aim is to investigate the cholinergic denervation in patients with DLB using 18F-FEOBV. The investigators plan to recruit 30 patients with DLB and 20 healthy controls to extensive cognitive assessment, computed and positron emission topography, magnetic resonance imaging, and samples of blood. The investigators hypothesize that patients with DLB, compared to controls, have decreased cholinergic innervation in cortical and subcortical areas of the brain, intestines and heart, and that the denervation corresponds to symptoms of autonomic and cognitive dysfunction.

Conditions

  • Dementia With Lewy Bodies
  • Degeneration Nerves
  • Positron-Emission Tomography
  • Acetylcholine

Interventions

RADIATION

PET-CT using FEOBV

We will inject 300 MBq of 18F-FEOBV in a peripheral vein and scan the internal organs from (0-70 minutes). The patient then rests, and from 180-210min after injection, we will scan the brain on our Siemens High Resolution Research Tomograph.

RADIATION

MRI-scan

All patients will have an MRI scan of the brain. T1-weighted images will be used to assess general anatomy and identify white matter. T2-weighted sequences will be performed to quantify competing brain pathology. Also, we will collect functional MRI data.

DIAGNOSTIC_TEST

Cognitive assessment

Full neuropsychometric examination including tests in 5 cognitive domains.

DIAGNOSTIC_TEST

Clinical assessment

Age, sex, duration of disease, patient history and full somatic and neurological examinations. Constipation assessed with Rome-III criteria. Evaluation of Rapid Eye Movement (REM) sleep Behaviour Disorder (RBDSQ) questionnaire. Test for orthostatic hypotension, heart rate variability, and deep breathing.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Per Borghammer, MD, DMSc · University of Aarhus

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04291144 on ClinicalTrials.gov