4RTNI
Four Repeat Tauopathy Neuroimaging Initiative
Longitudinal multi-site natural history study of progressive supranuclear palsy, corticobasal syndrome and related 4-repeat tauopathies with healthy controls, with 3T MRI, PET, biofluids and clinical ratings shared through LONI after an approved application.
Overview
The Four Repeat Tauopathy Neuroimaging Initiative (4RTNI) is an observational natural history study of progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD), the two main 4-repeat tauopathies. It is led from the Memory and Aging Center at UCSF and funded by the National Institute on Aging and the Tau Research Consortium. Its aim is to find imaging, fluid and clinical measures that track disease progression well enough to size therapeutic trials. Data are distributed by LONI through the Image and Data Archive, together with the companion FTLDNI study, after an application and a data use agreement.
Composition
The study ran in two cycles. Cycle 1 (2011 to 2016) enrolled people with a clinical diagnosis of PSP or CBD aged 45 to 90. Cycle 2 (4RTNI-2, 2016 to 2024) enrolled 293 participants aged 40 to 80: people with corticobasal syndrome or CBD, PSP, oligosymptomatic or variant PSP and nonfluent variant primary progressive aphasia, plus healthy volunteers. Participants needed a study partner and had to be able to walk a few steps. Follow-up visits took place at about 6 months, 1 year and 2 years.
Acquisition
Sites in cycle 2 were UCSF, UCSD, Johns Hopkins, Massachusetts General Hospital, Mayo Clinic Rochester, Columbia, the University of Pennsylvania and the University of Toronto. Structural MRI was acquired at 3T on Siemens Tim Trio, GE MR750 and GE Signa HDx systems with 1 mm isotropic T1-weighted MPRAGE or IR-SPGR sequences. Cycle 2 also planned tau PET, amyloid PET, retinal imaging and eye movement recordings. In cycle 1 a subset had amyloid PET with Pittsburgh compound B or florbetapir. Blood, urine and cerebrospinal fluid were collected as well.
Annotations
Clinical diagnoses follow consensus criteria for PSP Richardson syndrome, corticobasal syndrome and nonfluent variant primary progressive aphasia. Clinical ratings include the PSP Rating Scale, the CBD Functional Scale and the UDS neuropsychological battery with the FTLD module. Some participants have autopsy-confirmed pathology.
Known limitations
No data descriptor reports the size of the shared imaging release, so only the cycle 2 enrollment is given here. Cycle 1 lists only an estimated enrollment. Clinical diagnosis of corticobasal syndrome does not imply CBD pathology, and some participants have Alzheimer's disease biomarkers. Follow-up is incomplete for part of the cohort.
License and access
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A research proposal is reviewed and approved
4RTNI and FTLDNI Data Use Agreement
One click-through agreement covers both 4RTNI and FTLDNI data on the LONI IDA. Use is for scientific investigation, teaching or planning clinical research, as stated in a data use application. Redistribution in any form is prohibited, and publications must credit the initiative in the by-line, methods and funding text.
What you can do
- Not stated
- Not stated
- Not stated
- Yes
- Conditional
What you can share
- No
- No
- Not stated
What you must do
- Yes
- Share alike No
- Yes
- Conditional
- Manuscript review No
- Release code No
- Return results No
- Delete after use No
Limits
- Yes
- No
Citation
The data use agreement requires the by-line phrase "for the 4-Repeat Tauopathy Neuroimaging Initiative*", the statement "Data used in preparation of this article were obtained from the 4-Repeat Tauopathy Neuroimaging Initiative (4RTNI) database (http://4rtni-ftldni.ini.usc.edu)", a methods paragraph on 4RTNI and the funding acknowledgement (NIH grant R01 AG038791 and the Tau Research Consortium).
All numbers
Every number on this page, as stored in stats.csv, with its source.
| Measure | Breakdown | Value | Source |
|---|---|---|---|
| Subjects | total cycle 2 (4RTNI-2, 2016 to 2024) actual enrollment only; cycle 1 (NCT01804452, 2011 to 2016) lists only an estimated 110 and is not counted, and overlap between cycles is not reported | 293 | ctgov-nct02966145 Study design (enrollment) |
Sources
The keys used in the table above.
- dutt2016 Dutt S et al. 2016, Progression of brain atrophy in PSP and CBS over 6 months and 1 year, Neurology paper
- garciacastro2026 García-Castro J et al. 2026, Potential role of MRI to optimize clinical trial design for progressive supranuclear palsy and corticobasal degeneration, The Journal of Prevention of Alzheimer's Disease paper
- ctgov-nct01804452 ClinicalTrials.gov NCT01804452, 4 Repeat Tauopathy Neuroimaging Initiative (cycle 1) website
- ctgov-nct02966145 ClinicalTrials.gov NCT02966145, 4-Repeat Tauopathy Neuroimaging Initiative - Cycle 2 website