Comparing imaging techniques for diagnosing Parkinson's disease and related conditions

Prospective Head-to-head Comparison of Cardiac [18F]-MFBG PET Versus [123I]-MIBG SPECT in the Differentiation Between Parkinson's Disease and Multiple System Atrophy and Between Dementia With Lewy Bodies and Alzheimer's Disease

This study is testing two different imaging techniques to see which one better helps doctors tell apart Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and Alzheimer's disease in patients and healthy volunteers.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 113 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Universitaire Ziekenhuizen KU Leuven (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Ghent, Gent and 1 other locations)
• Trial ID: NCT06120049 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of [18F]-MFBG PET in assessing cardiac innervation compared to [123I]-MIBG SPECT. The study focuses 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). Participants will undergo multiple imaging sessions to assess the accuracy and feasibility of these imaging techniques in detecting myocardial changes associated with these conditions. The trial will include healthy volunteers and patients with confirmed diagnoses of PD, MSA, DLB, and AD.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 45-85 with clinically established Parkinson's disease, MSA, DLB, or Alzheimer's disease.

Not a fit: Patients with major neurological, internal, or psychiatric disorders, or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnostic methods for differentiating between neurodegenerative diseases, improving patient management.

How similar studies have performed: Previous studies have shown promise in using similar imaging techniques, but this specific comparison of [18F]-MFBG PET with [123I]-MIBG SPECT is novel.

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.

Where this trial is running

Ghent, Gent and 1 other locations

• UZ Ghent — Ghent, Gent, Belgium (Recruiting)
• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)

Study contacts

• Principal investigator: Koen Van Laere — Professor at KULeuven, department head of nuclear medicine at UZ Leuven
• Study coordinator: Koen Van Laere, Prof. dr.

Conditions Parkinson Disease; Dementia With Lewy Bodies; MSA - Multiple System Atrophy; Alzheimer Disease; Dementia with Lewy Bodies; [18F]-MFBG; [18F]-PE2I; [123I]-MIBG