Optimization of Morphomer-based Alpha-synuclein PET Tracers

NCT05067192 | Completed

• 1 other identifier: A-synuclein-PET-study
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Dementia With Lewy Bodies; Multiple System Atrophy; Corticobasal Degeneration; Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• Detection of alpha-synuclein pathology

  Assess the ability of alpha-synuclein tau tracer \[18F\]-ACI3847 in detecting tau pathology in synucleinopathies.

  July 2020 - August 2022

Study Arms (6)

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with synucleinopathies (PD, DLB and MSA), patients with other Parkinson Plus disorders (CBS, PSP) and controls.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Skane University Hospital: lead
• AC Immune SA: collaborator

Study Sites (1)

Skåne University Hospital, Dept of Neurology

Lund, Skåne County, 22185, Sweden

Location

MeSH Terms

Conditions

Parkinson Disease; Lewy Body Disease; Multiple System Atrophy; Corticobasal Degeneration; Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

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; Tauopathies; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Oskar Hansson, Professor

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 5, 2021
• Study Start: July 15, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-09

Locations

SE (1)