G23.2 G23.3 G20 G31.82 F02.8 G47.8 R41.8 F06.7 G30 G23.1 G23.8
Conditions
Interventions
Group 1: Single-center, scientific-experimental, prospective observational study with serial PET imaging.
As the study does not aim to assess the diagnostic efficacy of PET within an interventional se
Sponsors
Klinik und Poliklinik für Nuklearmedizin, Ludwig-Maximilians-Universität München
Eligibility
Sex/Gender
All
Age
51 Years to 85 Years
Inclusion criteria
Inclusion criteria: • Clinical suspicion of a neurodegenerative disease belonging to one of the following diagnostic groups: o Multiple system atrophy with a parkinsonian phenotype (MSA-P) o Multiple system atrophy with a cerebellar phenotype (MSA-C) o Idiopathic Parkinson’s disease (PD) o Parkinson’s disease dementia (PDD) o Dementia with Lewy bodies (DLB) o REM sleep behavior disorder (RBD) o Subjective cognitive decline with possible Alzheimer’s disease (SCD-AD) o Mild cognitive impairment with suspected Alzheimer’s disease (MCI-AD) o Alzheimer’s disease dementia o Progressive supranuclear palsy (PSP) o Corticobasal degeneration (CBD) o Behavioral variant frontotemporal dementia (bvFTD) o Semantic variant primary progressive aphasia (svPPA) • Willingness to undergo the study-related examinations after receiving comprehensive information about the purpose, procedures, duration, and potential risks of the study. • Provision of written informed consent. • Capacity to provide informed consent at the time of study inclusion: o generally considered present in participants with a current Montreal Cognitive Assessment (MoCA) score of =26 points; o in participants with a MoCA score <26 points, capacity to provide informed consent must be individually assessed and documented by the study physician. • The participant must demonstrate: o the ability to understand relevant information concerning the disease and the planned study procedures; o the ability to appreciate the nature, significance, scope, and potential risks of the study procedures and to apply this information to their own situation; o the ability to rationally process and compare relevant information and weigh available alternatives, including their potential risks, benefits, and consequences; o the ability to form and communicate a clear and unambiguous decision; and o the ability to determine and express their own will on the basis of an understanding of the information, insight into the disease and the proposed procedures, and an assessment of their individual situation. Control participants • Male or female participants aged 51–85 years. • Provision of written informed consent after comprehensive study information has been provided. • Capacity to provide informed consent according to the criteria listed above. • No clinical or diagnostic evidence of a relevant neurodegenerative disease. • Belonging to one of the following groups: o healthy control participants; o participants with essential tremor; or o participants with subjective cognitive decline without evidence of ß-amyloid pathology. For longitudinal follow-up examinations, renewed information and confirmation of consent by the participant—or, if decision-making capacity has been lost, by the legally authorized representative—are required for continued participation in the study.
Exclusion criteria
Exclusion criteria: • Underlying psychiatric disorders (e.g. substance use disorders, severe psychotic disorders, or depression with a Beck Depression Inventory [BDI] score >18) • Relevant medical conditions (e.g. severe renal or hepatic insufficiency, heart failure, coronary artery disease, sepsis, or poorly controlled diabetes mellitus) • Pregnancy and breastfeeding: Pregnant patients must not be included in the study because of radiation exposure and the associated risk of harm to the fetus. A pregnancy test will be performed in patients of childbearing potential; a positive result will preclude inclusion in the study. • Occupational or other radiation exposure exceeding 15 mSv per year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study Objectives The present study aims to use positron emission tomography (PET) to quantify reactive astrogliosis in the brains of patients and, in particular, to address the following research questions: Primary and Secondary Objectives a) Does the regional and quantitative extent of reactive astrogliosis differ between patients with different phenotypes of multiple system atrophy? b) Does the regional and quantitative extent of reactive astrogliosis differ between other manifestations of a-synucleinopathies, including idiopathic Parkinson’s syndrome (IPS), Parkinson’s disease dementia (PDD), dementia with Lewy bodies (DLB), and rapid eye movement sleep behavior disorder (RBD)? c) Does reactive astrogliosis differ between patients with Alzheimer’s disease at the clinical stages of subjective cognitive decline, mild cognitive impairment, and manifest dementia? d) Does reactive astrogliosis differ between patients with primary tauopathies within the frontotemporal disease spectrum, including progressive supranuclear palsy and corticobasal degeneration, and patients with presumed tau-negative disorders within the frontotemporal disease spectrum, including the behavioral variant of frontotemporal dementia and the semantic variant of primary progressive aphasia? e) How does the extent of reactive astrogliosis in the brain change over a disease course of 1.5 years in patients with the disease entities described under objectives a–d? Do the quantitative changes differ depending on the underlying neuropathological characteristics? f) At study inclusion, does the quantitative and regional extent of reactive astrogliosis correlate with a-synuclein deposition in the disease entities described under objectives a and b? How does reactive astrogliosis change longitudinally in relation to a-synuclein deposition in these disease entities? g) Does astrocyte activation, referred to as the “astrocyte burst,” occur earlier than microglial activation in the stages of Alzheimer’s dis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures are correlation parameters between PET imaging and established diagnostic methods. | — |
Countries
Germany
Contacts
Public ContactMatthias Brendel
Klinik und Poliklinik für Nuklearmedizin, Ludwig-Maximilians-Universität München
Outcome results
None listed