The MOTIVE-PSP Initiative (NCT04691635) is a multi-center, longitudinal observational study designed to identify reliable biomarkers for progressive supranuclear palsy (PSP) diagnosis, phenotypization, and progression monitoring over a 1-year follow-up period["@nct"].
This initiative represents a critical effort to address the pressing need for objective biomarkers in PSP clinical research, which has historically relied on subjective clinical assessments that may miss subtle disease progression.
Trial Details
| Parameter | Value | |-----------|-------| | NCT ID | NCT04691635 | | Status | Completed | | Phase | Observational | | Study Design | Multi-center, prospective longitudinal | | Duration | 1 year | | Cohort Size | ~200 PSP patients | | Sponsor | Multiple academic centers | | Collaborators | CurePSP, PSP Association |
Study Objectives
Primary Objectives
Motor Assessment Biomarkers
Evaluate standardized clinical motor scales as diagnostic biomarkers
Assess sensitivity to progression over 1 year
Compare quantitative vs. qualitative measures
Cognitive Function Assessment
Characterize cognitive phenotype changes over time
Identify cognitive biomarkers for disease staging
...
MOTIVE PSP Initiative
Overview
Mermaid diagram (expand to render)
The MOTIVE-PSP Initiative (NCT04691635) is a multi-center, longitudinal observational study designed to identify reliable biomarkers for progressive supranuclear palsy (PSP) diagnosis, phenotypization, and progression monitoring over a 1-year follow-up period["@nct"].
This initiative represents a critical effort to address the pressing need for objective biomarkers in PSP clinical research, which has historically relied on subjective clinical assessments that may miss subtle disease progression.
Trial Details
| Parameter | Value | |-----------|-------| | NCT ID | NCT04691635 | | Status | Completed | | Phase | Observational | | Study Design | Multi-center, prospective longitudinal | | Duration | 1 year | | Cohort Size | ~200 PSP patients | | Sponsor | Multiple academic centers | | Collaborators | CurePSP, PSP Association |
Study Objectives
Primary Objectives
Motor Assessment Biomarkers
Evaluate standardized clinical motor scales as diagnostic biomarkers
Assess sensitivity to progression over 1 year
Compare quantitative vs. qualitative measures
Cognitive Function Assessment
Characterize cognitive phenotype changes over time
Identify cognitive biomarkers for disease staging
Language and Speech Biomarkers
Assess speech and language function using standardized batteries
Evaluate potential for early detection
Secondary Objectives
Cerebrospinal Fluid Biomarkers
Measure tau species (total tau, phosphorylated tau)
Identify novel CSF markers of disease progression
Correlate with clinical measures
Neuroimaging Progression Markers
MRI-based volumetric analysis
Diffusion tensor imaging changes
Tau PET signal correlation
Study Design
Assessment Schedule
| Timepoint | Assessments | |-----------|-------------| | Baseline | Full motor, cognitive, CSF, MRI battery | | 3 months | Motor scales, cognitive tests | | 6 months | Full battery | | 9 months | Motor scales, cognitive tests | | 12 months | Full battery (primary endpoint) |
Patient Population
Diagnosis: Probable PSP (Richardson syndrome or PSP variants)
[Tau Biomarkers in Neurodegeneration](/biomarkers/tau-biomarkers)](/diseases/neurodegeneration)
[Digital Health in Neurology](/therapeutics/digital-health)](/therapeutics)
[Remote Monitoring in PSP](/clinical-trials/remote-monitoring-psp-nct04753320)
Clinical Significance for Patient Care
Personalized Medicine
The MOTIVE-PSP Initiative contributes to personalized treatment approaches in several ways:
Biomarker-Driven Diagnosis: Objective measures can confirm clinical diagnosis
Progression Monitoring: Track individual patient trajectory more accurately
Treatment Response: Objective endpoints for evaluating therapy effectiveness
Prognostic Counseling: Better predictions of disease course
Healthcare System Impact
Implementing biomarker-based approaches in PSP care could:
[Reduce diagnostic delays through earlier](/genes/ar)objective testing
Enable proactive care planning as disease progresses
Improve resource allocation based on disease stage
Facilitate telehealth monitoring between in-person visits
Research Network Benefits
The collaborative nature of this initiative establishes:
Standardized protocols for multi-site studies
Shared data repositories for aggregate analysis
Training programs for consistent assessment
Infrastructure for future therapeutic trials
Additional Digital Endpoint Studies
Syde® Digital Endpoints Study (NCT07389018)
A related study (NCT07389018) is evaluating the feasibility of Syde® digital endpoints for monitoring patients with PSP-Richardson syndrome. This study:
[Shoenfeld K, et al. Digital endpoints in movement disorders: The future of clinical trials (2019)](https://doi.org/10.14802/jmd.19067)
[Pavel M, et al. Wearable sensors for objective monitoring of gait and balance in Parkinson's disease (2020)](https://doi.org/10.1038/s41531-020-00134-4)
[Schneider SA, et al. Motor and non-motor biomarkers in progressive supranuclear palsy (2022)](https://doi.org/10.1038/s41582-022-00691-0)
[NCT07389018 - Syde Digital Endpoints Study](https://clinicaltrials.gov/study/NCT07389018)