[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD

Launched by PROF. DR. KOEN VAN LAERE · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique called [18F]-MFBG PET to see how well it can assess heart function in patients with different types of neurodegenerative diseases, specifically Parkinson's Disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB), and Alzheimer’s Disease (AD). The main goal is to compare the effectiveness of [18F]-MFBG PET with another imaging method, [123I]-MIBG SPECT, to determine if it can accurately tell these conditions apart based on heart activity.

To participate, individuals must be between the ages of 45 and 85 for PD and MSA, or between 50 and 85 for DLB and AD. Participants will need to visit the hospital for three or four appointments, where they will undergo various tests, including brain scans and heart imaging. Healthy volunteers aged 18 to 85 can also join the study for a separate part. It's important for potential participants to be in good health and to understand the study process, as those with certain medical conditions or who have taken specific medications may not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Healthy Controls:
• • Voluntary written informed consent.
• • Use of highly effective methods of birth control.
• • Age between 18 and 85 years.
• • Good health based on medical history, physical examination, clinical laboratory tests, and urinalysis.
• • No history or evidence of major neurological, internal, or psychiatric disorders.
• • Normal structural MRI scan for subjects \< 60 years or minor lesions for subjects \>= 60 years.
• 2. Parkinson's Disease:
• • Age 45-85 years.
• • Clinically established PD based on Movements Disorder Society diagnostic criteria.
• • Disease duration since onset of motor symptoms: 5 years or longer for one group and less than 5 years for another.
• • Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
• • Ability to understand the patient information brochure and provide written informed consent.
• 3. Multiple System Atrophy - Parkinsonian Variant:
• • Age 45-85 years.
• • Clinically established or clinically probable MSA-P based on MDS diagnostic criteria.
• • Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
• • Ability to understand the patient information brochure and provide written informed consent.
• 4. Dementia Due to Alzheimer's Disease:
• • Age 50-85 years.
• • Diagnosis of probable AD with evidence of the AD pathophysiological process.
• • Ability to understand the patient information brochure and provide written informed consent.
• 5. Dementia with Lewy Bodies:
• • Age 50-85 years.
• • Diagnosis of probable DLB.
• • Previous abnormal \[18F\]-FE-PE2I PET or \[123I\]-FP-CIT SPECT scan.
• • Ability to understand the patient information brochure and provide written informed consent.
• Exclusion Criteria:
• 1. Healthy controls:
• • Major diseases that may interfere with the investigations.
• • Evidence of cognitive impairment.
• • History or evidence of psychiatric disease.
• • Use of illicit drugs or history of drug or alcohol abuse.
• • Chronic medication interfering with cardiac neuronal norepinephrine transporter (NET) or \[18F\]-FE-PE2I imaging.
• • Exposure to ionizing radiation \> 1 mSv in other research studies within the last 12 months.
• • Contraindication for MRI scanning.
• • Claustrophobia or inability to tolerate confinement during PET-MRI scanning.
• • Unwillingness to avoid strenuous physical activity.
• • Lack of understanding of the study procedures.
• • Pregnancy or breastfeeding.
• • Lack of agreement to communicate incidental findings to the general practitioner.
• • Abnormal Allen test or lidocaine hypersensitivity/allergy for subjects willing to undergo arterial sampling.
• 2. Parkinson's Disease:
• • Neuropsychiatric diseases other than PD.
• • Major internal medical comorbidity, especially diabetes or heart disease.
• • White matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities.
• • History of alcohol or drug abuse.
• • Previous participation in research studies involving ionizing radiation.
• • Contraindications for MR.
• • Claustrophobia or inability to tolerate confinement during PET scanning.
• • Unwillingness to avoid strenuous physical activity.
• • Lack of understanding of the study procedures.
• • Pregnancy or breastfeeding.
• • Lack of agreement to communicate incidental findings to the general practitioner.
• • Anticoagulant therapy.
• 3. Multiple System Atrophy - Parkinsonian Variant:
• • Same as for Parkinson's disease.
• 4. Dementia Due to Alzheimer's Disease:
• • Same as for Parkinson's disease.
• 5. Dementia with Lewy Bodies:
• • Same as for Parkinson's disease.