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Optimization of Morphomer-based Alpha-synuclein PET Tracers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05067192
Recruitment Status : Completed
First Posted : October 5, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
AC Immune SA
Information provided by (Responsible Party):
Oskar Hansson, Skane University Hospital

Brief Summary:

The aim of the project is to develop the first alpha-synuclein (a-syn)-specific PET tracer. The research phase will exploit ACI's proprietary MorphomerTM library and extensively optimized screening workflow.

Promising PET-tracer candidates will be tested for their ability in detecting a-syn pathology in patients with a range of Parkinsonian conditions with different a-syn levels and distributions, comprising hereditary forms of PD and other synucleinopathies.


Condition or disease
Parkinson Disease Dementia With Lewy Bodies Multiple System Atrophy Corticobasal Degeneration Progressive Supranuclear Palsy

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Optimization of Morphomer-based Alpha-synuclein PET Tracers
Actual Study Start Date : July 15, 2021
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 1, 2021


Group/Cohort
Parkinson's Disease
Patients with Parkinson's Disease. Patients will undergo [18F]ACI-3847 PET, [18F]DOPA PET and MRI. Up to 20 patients will be scanned
Dementia with Lewy Bodies
Patients with Dementia with Lewy Bodies. Patients will undergo [18F]ACI-3847 PET, [18F]DOPA PET and MRI. Up to 10 patients will be scanned
Multiple System Atrophy
Patients with Multiple System Atrophy. Patients will undergo [18F]ACI-3847 PET, [18F]DOPA PET and MRI. Up to 10 patients will be scanned
Corticobasal Syndrome
Patients with Corticobasal Syndrome. Patients will undergo [18F]ACI-3847 PET, [18F]DOPA PET and MRI. Up to 10 patients will be scanned
Progressive Supranuclear Palsy
Patients with Progressive Supranuclear Palsy. Patients will undergo [18F]ACI-3847 PET, [18F]DOPA PET and MRI. Up to 10 patients will be scanned
Healthy controls
Healthy contols. Contols will undergo [18F]ACI-3847 PET, [18F]DOPA PET and MRI. Up to 20 patients will be scanned



Primary Outcome Measures :
  1. Detection of alpha-synuclein pathology [ Time Frame: July 2020 - August 2022 ]
    Assess the ability of alpha-synuclein tau tracer [18F]-ACI3847 in detecting tau pathology in synucleinopathies.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with synucleinopathies (PD, DLB and MSA), patients with other Parkinson Plus disorders (CBS, PSP) and controls.
Criteria

Inclusion Criteria:

  • Age 50-100 years.
  • Fulfill the criteria for PD, DLB, MSA, PSP or CBS. Alongside with these participants patients with duplications in the gene coding for a-synuclein will be included.
  • Absence of cognitive symptoms or parkinsonism as assessed by a physician with special interest in cognitive disorders (Healthy controls).
  • Speaks and understands Swedish to the extent that an interpreter was not necessary for the patient to fully understand the study information and cognitive tests.

Exclusion Criteria:

  • Significant unstable systemic illness or organ failure, such as terminal cancer, that makes it difficult to participate in the study.
  • Current significant alcohol or substance misuse.
  • Refusing MRI or PET.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05067192


Locations
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Sweden
Skåne University Hospital, Dept of Neurology
Lund, Skåne, Sweden, 22185
Sponsors and Collaborators
Skane University Hospital
AC Immune SA
Investigators
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Principal Investigator: Oskar Hansson, Professor Skane University Hospital
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Responsible Party: Oskar Hansson, Professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT05067192    
Other Study ID Numbers: A-synuclein-PET-study
First Posted: October 5, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Lewy Body Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Dementia
Neurocognitive Disorders
Mental Disorders
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Paralysis
Neurologic Manifestations
Eye Diseases