4 Repeat Tauopathy Neuroimaging Initiative – Cycle 2 (4RTNI-2)

Purpose of the Study

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.”

Study Details

Inclusion Criteria: Participants must be between the ages of 40 and 80. They must also have 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). Participants will need 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. All participants must be willing and able to undergo testing procedures, which include longitudinal follow-up visits. Participants must be able to walk five steps with minimal assistance.

Exclusion Criteria: Other than those listed above, any significant neurological disease, including Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal-pressure hydrocephalus, brain tumor, seizure disorder, subdural hematoma and multiple sclerosis. Also exclusionary is a history of significant head trauma followed by persistent neurological deficits or known structural abnormalities. Any significant systemic illness or unstable/uncontrolled medical condition is exclusionary. The presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or metal fragments or metal objects in the eyes, skin, or body is exclusionary. No longstanding history (longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed. No longstanding history (longer than 10 years) of major depression, bipolar disorder or schizophrenia that has had continuous or intermittent symptoms similar to the clinical presentation and that required medication control up until the time of evaluation. No clinically significant abnormalities in B12, RPR or TFTs that may interfere with the study are exclusionary. A participant is also ineligible if the study director deems that the participant will be unable to complete sufficient key study procedures; exceptions to these guidelines may be considered on a case-by-case basis by the study director.

What to Expect

Testing: Participants may be asked to undergo the following testing procedures, though not all participants will be asked to undergo every procedure listed: neurological and physical examinations; interviews with the study partner; MRI scans of the brain; PET scans of the brain; eye movement testing; retinal imaging; memory & thinking testing, daily-function assessments; computer-based tests of decision-making and executive abilities; collection of a detailed family history; blood and urine collection for analysis and storage/banking; behavioral testing; speech and language evaluations; mood questionnaires; and optional lumbar punctures (LPs), either conventional and CT-guided, to collect cerebrospinal fluid (CSF) for analysis and storage.

The Frequency of Visits: All participants will be asked for one visit every six months for 12 months (i.e., a total of three visits over one year). o/vPSP and healthy volunteer participants will be asked for an additional visit approximately 12 months after the third visit (i.e., three visits over the first year and then one additional visit two years after the start of the study, for a total of four visits over two years). MRI brain scans will occur at the UCSF Neuroscience Imaging Center. PET brain scans will occur at Lawrence Berkeley National Laboratory. The remainder of the study procedures will occur at the UCSF Memory and Aging Center or the UCSF Neurosciences Clinical Research Unit.

Materials Needed Before Evaluation: Medical records and MRI scans (if available).

Costs: No costs will be charged for any of the study procedures. In return for time, effort and travel expenses, participants will receive $40 for each visit completed, $50 for each MRI brain scan, $50 for the PiB PET scan, $100 for each AV1451 PET scan and $100 for every lumbar puncture.

Contact Information

If you are interested in participating in this study or have any questions, please contact the study coordinator, Dan Luong, at Phi.Luong@ucsf.edu or 415.476.9578.