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

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-02-06