Imaging Tests for Parkinson's and Related Conditions
[18F]-MFBG Versus [123I]-MIBG and [18F]-PE2I in PD vs. MSA and DLB vs. AD
Recruiting
Phase 2Phase 3Interventional Study
Parkinson DiseaseDementia With Lewy BodiesMSA - Multiple System AtrophyAlzheimer Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Diagnostic
Participants needed
113 (estimated)
Sponsor
prof. dr. Koen Van Laere · Other
Who this trial is looking for
This trial is looking for people with Parkinson's disease, Alzheimer's disease, or related conditions to participate in imaging tests. Participants will need to visit the hospital for several appointments to undergo various scans and assessments.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 45 and 85 years old.
I have been diagnosed with Parkinson's disease or a related condition.
I can understand the patient information and give consent.
I am in good health and have no major illnesses.
You may not be able to join if
I have a history of major psychiatric disorders.
I have cognitive impairment or major internal diseases.
I have had previous research involving radiation exposure in the last year.
I am pregnant or breastfeeding.
I have claustrophobia or can't tolerate being confined.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 questio…
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? How well can it differentiate between these groups based on the detected changes?
* Non-inferiority: Is \[18F\]-MFBG PET as accurate as \[123I\]-MIBG SPECT in distinguishing between PD and MSA-P, and between DLB and AD?
Participant requirements:
For the main study, participants will be required to visit the hospital for 3 or 4 appointments. During these visits, they will undergo a screening visit, MRI brain scan, a comprehensive neurological assessment, \[18F\]-PE2I PET, \[123I\]-MIBG SPECT, and \[18F\]-MFBG PET scans.
Additionally, a separate dosimetry study will be conducted, involving healthy subjects who will visit the hospital for a screening visit and undergo \[18F\]-MFBG PET scans.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.