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Compares treatment options for Parkinson Disease
Official title [18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD
ClinicalTrials.gov ID: NCT06120049
What this study is testing
- What it's testing
- Study goal: The goal of this prospective head to head comparison is to evaluate the effectiveness of [18F]-MFBG PET in assessing cardiac innervation, comparing it with [123I]-MIBG SPECT The study's primary focus is on distinguishing between Parkinson's disease (PD) and multiple system atrophy (MSA), as well as between dementia with Lewy bodies (DLB) and Alzheimer's disease (AD). Main questions: Feasibility: How well can [18F]-MFBG PET detect changes in myocardial uptake in PD and DLB compared to the expected normal values in healthy individuals and AD and MSA-P patients?
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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 people \ = 60 years.
- 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.
- 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.
- 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.
- 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.
- 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 people willing to undergo arterial sampling.
- 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.
- Multiple System Atrophy - Parkinsonian Variant:
- Same as for Parkinson's disease.
- Dementia Due to Alzheimer's Disease:
- Same as for Parkinson's disease.
- Dementia with Lewy Bodies:
- Same as for Parkinson's disease.
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, Gent, Belgium
- Leuven, Vlaams-Brabant, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, Gent, Belgium; Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.