Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT05486806

Conditions

Neurodegenerative Diseases

sca3

MSA - Multiple System Atrophy

Ataxia

Synucleinopathies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-PBR06

18F-PBR06

Study Details

Brief summary:

The purpose of this protocol is to create an active natural history cohort of patients with degenerative movement disorders, tracked in a clinical setting with clinical rating scales and neuroimaging. The overarching rationale is that neurodegenerative diseases may be heterogeneous, complex disorders. A new way of performing clinical trials in these patients may be in order and this protocol aims to build a longitudinally tracked clinical trial-ready cohort of patients. The purpose of this protocol is to establish an active natural history cohort of patients with neurodegenerative movement disorders who are deeply phenotyped and "clinical trial ready" across Mass General Brigham.

After a thorough clinical diagnostic evaluation (this may include clinically indicated testing, for example MRI, FDG-PET, MIBG scan, polysomnography, genetic testing, autonomic function tests, inflammatory tests, skin biopsy) the investigators aim to achieve this through:

1. Longitudinal tracking of clinical progression through use of clinical scales including at the present time: UMSARS, BARS, MoCA and UPSIT, PROM, MDS-NMS, UPDRS, and SARA
2. Longitudinal tracking of disease progression through use of neuroimaging including at the present time: TSPO-PET and 3D MRI (see section 1.3)

This is a pilot study designed to track patients with neurodegenerative movement disorders across Mass General Brigham through MRI and PET imaging modalities and clinical measures. Figure 5 represents the study design in detail. In short, subjects will be asked to visit Mass General Brigham every 6-9 months over the course of 18 months for imaging and clinical evaluation.

Conditions

Neurodegenerative Diseases

sca3

MSA - Multiple System Atrophy

Ataxia

Synucleinopathies

Study ID

NCT05486806

Start date

Mar 1, 2023

Status verified date

May, 2023

Completion date

Nov 15, 2024

Anticipated

Primary completion date

Sep 15, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Clinical diagnosis of neurodegenerative movement disorder by consensus criteria including: MSA, ataxias, synuclein duplication, atypical parkinsonism
2. Male and female subjects aged 18 and up

Exclusion Criteria:

1. Individuals with a known alternate neurologic disorder including: idiopathic PD, DLB, PSP, ALS, Alzheimer's, prion disease, frontotemporal dementia, seizure disorder, stroke, or brain tumor
2. Individuals with a previous head injury (with 15 minutes or greater loss of consciousness within the past 20 years)
3. Individuals with substance abuse, or substance abuse disorder
4. Brain MRI indicative of a significant abnormality (i.e. prior hemorrhage or infarct greater than 1 cm3, 3 or more lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space- occupying lesion).
5. Individuals with bipolar disease and schizophrenia
6. Concurrent medical conditions that contraindicate study procedures
7. Women who are pregnant, nursing, or seeking to become pregnant
8. Individuals with claustrophobia
9. Non-MRI compatible implanted devices
10. Corticosteroid treatment in the past four weeks
11. Low affinity binders to TSPO
12. Significant cognitive impairment (MoCA score ≤ 23) or poor understanding of study design

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

participants

all participants in this study must have a diagnosis of a neurodegenerative movement disorder

Interventions

18F-PBR06

TSPO-PET (translocatior protein, positron emission tomography) scan

18F-PBR06

TSPO-PET (translocatior protein, positron emission tomography) scan

Primary outcome measure

  • association between change in PET and clinical measures [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

May 22, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2023-05-22.