4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify the most reliable methods of analysis for tracking CBD, PSP, and o/vPSP over time. The results from this study may be used in the future to calculate statistical power for clinical drug trials. The study will also provide information about the relative value of novel imaging techniques for diagnosis, as well as the value of imaging techniques versus testing of blood, urine, and cerebrospinal fluid (CSF) 'biomarkers'.

Official Title
-----------------
The Four-Repeat Tauopathy Neuroimaging Initiative

Conditions
-----------------
Corticobasal Degeneration (CBD), Corticobasal Syndrome (CBS), Cortical-basal Ganglionic Degeneration (CBGD), Progressive Supranuclear Palsy (PSP), Nonfluent Variant Primary Progressive Aphasia (nfvPPA), Oligosymptomatic/Variant Progressive Supranuclear Palsy (o/vPSP)

Intervention / Treatment
-----------------
* Other: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No known history of neurological disease, or meet criteria for one of the following: Corticobasal Syndrome or Degeneration (CBS or CBD); Progressive Supranuclear Palsy (PSP); or Oligo- or Variant- Progressive Supranuclear Palsy (o/vPSP) Needs a reliable study partner who has frequent contact with the participant, who is available to provide information about the participant, and who can accompany the participant to research visits as needed Must be willing and able to undergo testing procedures, which include longitudinal follow-up visits Must be able to walk five steps with minimal assistance Exclusion Criteria: Significant neurological disease other than CBD, PSP, or a variant PSP syndrome. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal fragments or metal objects in the eyes, skin, or body In the site investigator's opinion, inability to complete sufficient key study procedures, or some other equivalent assessment of impairment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PSP & CBD<br>Observational study of participants with a diagnosis of Progressive Supranuclear Palsy or Corticobasal Degeneration (also called Corticobasal Syndrome or Cortical-basal Ganglionic Degeneration). | Other: Observational Study<br> <br> |
| o/vPSP<br>Observational study of participants with a diagnosis of an oligosymptomatic or variant Progressive Supranuclear Palsy syndrome. | Other: Observational Study<br> <br> |
| Normal Volunteers<br>Observational study of participants with no known diagnosis of a neurological or neurodegenerative condition, and no known history of memory complaints. | Other: Observational Study<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tau-PET Brain Scan | Change from Baseline of Tau protein distribution in the brain. | Baseline, 1-year, and 2-years. | 
| Amyloid-PET Brain Scan | Presence of Amyloid in the brain at Baseline. | Baseline | 
| Brain Volume on MRI | Change from Baseline of brain tissue volume. | Baseline, 6-months, 1-year, and 2-years. | 
| Progressive Supranuclear Palsy Rating Scale (PSPRS) | Change from Baseline of this rating scale. | Baseline, 6-months, 1-year, and 2-years. | 
| Corticobasal Degeneration Functional Scale (CBDFS) | Change from Baseline of this rating scale. | Baseline, 6-months, 1-year, and 2-years. | 
| Eye Movement Function | Change from Baseline of eye movement function. | Baseline, 6-months, 1-year, and 2-years. | 
| Retinal Imaging | Change from Baseline of retinal thickness. | Baseline, 6-months, 1-year, and 2-years. | 
| UDS Neuropsychological Testing Battery, including supplemental FTLD Module | Change fromm Baseline of cognitive function. | Baseline, 6-months, 1-year, and 2-years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBD, CBS, CBGD, PSP, nfvPPA, oPSP, vPSP, o/vPSP, Corticobasal Degeneration, Corticobasal Syndrome, Cortocal-basal Ganglionic Degeneration, Progressive Supranuclear Palsy, Nonfluent Variant Primary Progressive Aphasia, Oligosymptomatic Progressive Supranuclear Palsy, Variant Progressive Supranuclear Palsy, Biomarker, Neuroimaging, MRI, PET, Tau, Oculomotor, Retinal Imaging