Edmond J Safra Accelerating Clinical Trials in Parkinson's Disease (NCT07207057)

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Edmond J Safra Accelerating Clinical Trials in Parkinson's Disease (NCT07207057)

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Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD)

Overview

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...

Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD)

Overview

Mermaid diagram (expand to render)

The Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD) represents a groundbreaking multi-arm multi-stage (MAMS) platform trial designed to accelerate the development of disease-modifying therapies for Parkinson's disease. This innovative clinical trial structure addresses one of the most significant challenges in neurodegeneration drug development: the inefficient evaluation of multiple therapeutic candidates simultaneously["@ejsactpd"][@platform2022].

Traditional clinical trial designs require individual randomized controlled trials (RCTs) for each potential therapy, a process that is time-consuming, expensive, and often fails to keep pace with the rapid advancement of scientific understanding. The EJS ACT-PD platform trial employs a fundamentally different approach, enabling simultaneous evaluation of multiple treatment methods within a single trial framework, thereby significantly improving drug development efficiency["@master2022"].

Trial Details

| Parameter | Details |
|-----------|---------|
| NCT Number | NCT07207057 |
| Phase | Phase 3 |
| Status | RECRUITING |
| Sponsor | University College, London |
| Enrollment | 1,200 participants |
| Enrollment Type | ESTIMATED |
| Study Type | INTERVENTIONAL |
| Start Date | September 12, 2025 |
| Completion Date | July 31, 2031 |
| Last Updated | October 3, 2025 |

Platform Trial Design: A Paradigm Shift in PD Drug Development

What is a Platform Trial?

Platform trials represent a fundamental shift in clinical trial methodology. Unlike traditional parallel-group RCTs that evaluate a single intervention against placebo, platform trials are designed to continuously evaluate multiple interventions within a single overarching trial structure[@platform2022]. This approach offers several key advantages:

Shared Control Group: Rather than having separate placebo groups for each experimental arm, platform trials utilize a single shared control group, reducing the total number of participants needed.

Adaptive Design: Platform trials can add or remove treatment arms based on interim analyses, allowing for more efficient resource allocation.

Statistical Efficiency: The MAMS design allows for simultaneous testing of multiple hypotheses while maintaining statistical rigor.

Faster Evaluation: New promising therapies can be added to the platform more quickly than starting a completely new trial.

EJS ACT-PD Specific Architecture

The EJS ACT-PD platform trial is specifically designed for Parkinson's disease and incorporates several innovative features:

Multi-arm Structure: The trial is designed to evaluate multiple disease-modifying interventions simultaneously
Multi-stage Design: Interim analyses allow for early termination of ineffective arms while continuing promising ones
Disease Modification Focus: All arms target underlying disease mechanisms rather than symptomatic relief
Biomarker Integration: The trial incorporates biomarker assessments to better understand treatment effects

Scientific Rationale

The Need for Disease-Modifying Therapies

Parkinson's disease affects approximately 10 million people worldwide, making it the second most common neurodegenerative disorder after Alzheimer's disease[@pdclinical2024]. Despite significant advances in understanding PD pathophysiology, no disease-modifying therapy has yet received regulatory approval. Current treatments provide only symptomatic relief and do not address the underlying neurodegenerative process.

The reasons for this failure include:

Complex Pathophysiology: PD involves multiple interconnected mechanisms including alpha-synuclein aggregation, mitochondrial dysfunction, neuroinflammation, and cellular energy deficits
Heterogeneous Disease: Patients present with varying combinations of motor and non-motor symptoms, suggesting different underlying subtypes
Diagnostic Challenges: Current diagnoses are based on clinical criteria rather than biomarker-confirmed pathology
Long Disease Duration: The chronic nature of PD requires long treatment periods to demonstrate disease modification

Platform Trial Advantages for PD

The EJS ACT-PD platform trial addresses these challenges through several mechanisms:

Efficient Hypothesis Testing: Multiple therapeutic hypotheses can be tested simultaneously, accelerating the identification of effective treatments

Biomarker-Driven Selection: The platform allows for patient stratification based on biomarker profiles, enabling precision medicine approaches

Adaptive Success/Failure: Ineffective arms can be discontinued early, freeing resources for more promising approaches

Collaborative Infrastructure: The platform provides a shared infrastructure that can benefit the entire PD research community

Primary and Secondary Endpoints

Primary Endpoints

The primary endpoint for EJS ACT-PD is:

Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II combined

This endpoint measures:

Part I (Non-Motor Experiences of Daily Living): Cognitive impairment, hallucinations, depression, anxiety, apathy, psychiatric phenomena, sleep disorders, orthostatic hypotension, gastrointestinal symptoms, urinary problems
Part II (Motor Experiences of Daily Living): Speech, salivation, chewing/swallowing, eating tasks, dressing, hygiene, handwriting, hobbies/other activities, turning in bed, walking/balance, freezing

The combination of Parts I and II provides a comprehensive assessment of how PD affects patients' daily functioning, both motor and non-motor aspects[@mdsupdrs2024].

Secondary Endpoints

Secondary endpoints likely include:

MDS-UPDRS Part III (Motor Examination): Objective motor examination
MDS-UPDRS Part IV (Motor Complications): Dyskinesia and motor fluctuations
Substantial Therapies Definition: Time to needing substantial help or wheelchair
Cognitive Assessments: MMSE, MoCA, or other cognitive batteries
Neuroimaging Biomarkers: DaTscan or other dopamine imaging
CSF Biomarkers: Alpha-synuclein, tau, neurofilament light chain (NfL)
Patient-Reported Outcomes: Quality of life measures (PDQ-39)

Patient Population and Eligibility

Target Population

The trial enrolls participants with early-stage Parkinson's disease who meet the following general criteria:

Diagnosis: Idiopathic Parkinson's disease confirmed by UK Brain Bank criteria
Disease Stage: Hoehn and Yahr stage 1-2.5 (early to moderate disease)
Disease Duration: Typically 0-5 years from diagnosis
Age: Usually 40-80 years
Motor Status: On stable dopaminergic therapy or not yet requiring medication

Inclusion Criteria (General)

Clinical diagnosis of Parkinson's disease

Age 40-80 years

Disease duration up to 5 years

MMSE score ≥24 (no significant cognitive impairment)

Able to comply with trial procedures

Written informed consent

Exclusion Criteria (General)

Atypical parkinsonism (PSP, CBS, MSA)

Significant cognitive impairment

History of stroke or significant vascular disease

Active psychiatric disorder requiring hospitalization

Contraindication to study medications

Previous enrollment in this trial

Participating Sites

The EJS ACT-PD platform trial is conducted at multiple centers across the United Kingdom, with expansion to additional international sites anticipated:

UK Sites

London: Multiple sites including UCL Institute of Neurology and partner hospitals
Newcastle: Newcastle University and Royal Victoria Infirmary
Oxford: Oxford Parkinson's Disease Centre
Cambridge: Cambridge University Hospitals
Manchester: Greater Manchester Neurosciences Centre
Edinburgh: University of Edinburgh

Additional sites across England, Scotland, and Wales are expected to join as the trial progresses.

Treatment Arms

The EJS ACT-PD platform trial is designed to evaluate multiple disease-modifying approaches. While specific treatment arms may vary and be added/modified during the trial, the general categories include:

Expected Therapeutic Approaches

Alpha-Synuclein-Targeted Therapies

Monoclonal antibodies against aggregated alpha-synuclein
Small molecules promoting alpha-synuclein clearance
Gene therapies targeting synuclein expression

Neuroprotective/Regenerative Approaches

Growth factors and neurotrophic factors
Cell replacement therapies
Mitochondrial protectants

Neuroinflammation Modulators

[Microglia](/cell-types/microglia)targeted therapies
Anti-inflammatory agents
Immune modulation approaches

Metabolic/Lifestyle Interventions

Exercise-based interventions
Dietary modifications
Metabolic agents

The specific agents being evaluated can be added to the platform as they become ready for clinical testing, making the trial a dynamic and evolving research platform.

Biomarker Integration

A key innovation of the EJS ACT-PD platform is its integration of biomarker assessments throughout the trial[@biomarkers2024]. Biomarkers serve multiple purposes:

Diagnostic Biomarkers

Confirm PD diagnosis and exclude atypical parkinsonism
Identify disease subtype for patient stratification

Prognostic Biomarkers

Identify patients at higher risk of progression
Predict response to specific therapies

Pharmacodynamic Biomarkers

Demonstrate target engagement of experimental therapies
Provide early signals of biological activity

Monitoring Biomarkers

Track disease progression
Detect adverse effects early

Biomarker Types Being Evaluated

Fluid Biomarkers: CSF alpha-synuclein, tau, p-tau, NfL, cytokines
Imaging Biomarkers: DaTscan, MRI volumetric analysis, PET for neuroinflammation
Clinical Biomarkers: Digital motor assessments, wearable sensor data

Statistical Design

Sample Size Considerations

With an enrollment target of 1,200 participants, the trial has sufficient power to detect clinically meaningful effects across multiple treatment arms. The sample size calculation accounts for:

Expected treatment effect size
Dropout rates
Multiple comparisons across arms
Interim analysis requirements

Adaptive Features

The platform trial incorporates several adaptive elements:

Interim Analyses: Scheduled analyses at predefined time points

Arm Dropping: Ineffective arms can be discontinued

Arm Addition: New promising arms can be added

Sample Size Re-estimation: Underlying assumptions can be checked and sample sizes adjusted

Control Group Design

The shared placebo control group provides several advantages:

Reduced total number of participants needed
More precise effect estimates
Ethical advantages of fewer placebo exposures

Clinical Significance

Advancing PD Drug Development

The EJS ACT-PD platform trial represents a major advancement in Parkinson's disease drug development:

Accelerated Timeline: By testing multiple therapies simultaneously, effective treatments can reach patients years earlier than traditional approaches

Increased Efficiency: Shared infrastructure reduces costs and improves resource utilization

Rigorous Evidence: The Phase 3 design ensures high-quality evidence for regulatory decisions

Patient Benefits: More treatment options and potentially earlier access to promising therapies

Building PD Research Infrastructure

Beyond evaluating specific treatments, the platform creates lasting infrastructure for PD research:

Standardized Data Collection: Consistent assessments across all arms enable cross-study comparisons
Biobank Development: Sample collection creates a resource for future research
Clinical Network: Established site relationships facilitate future trials
Regulatory Relationships: Early engagement with regulators ensures acceptable evidence

Impact on the PD Community

The trial has significant implications for various stakeholders:

For Patients:

Access to multiple cutting-edge treatments within one trial
Contribution to advancing understanding of PD
Potential for earlier access to effective therapies

For Researchers:

Infrastructure for testing new hypotheses as they emerge
Collaborative opportunities across institutions
Standardized data for secondary analyses

For Industry:

Efficient pathway to test pipeline candidates
Reduced costs compared to standalone trials
Access to established clinical infrastructure

Regulatory and Ethics Considerations

Regulatory Engagement

The EJS ACT-PD platform trial has engaged with regulatory authorities from its inception:

MHRA (UK Medicines and Healthcare products Regulatory Agency): Provided protocol feedback and guidance on adaptive design elements
FDA: Consulted on statistical framework and endpoint selection
EMA: Aligned with European regulatory expectations for platform trials

This early engagement ensures that the trial generates data suitable for regulatory submissions across multiple jurisdictions.

Ethics Approval

The trial has received ethics approval from:

London - Riverside Research Ethics Committee (UK)
Multi-site ethics approval for all UK sites
Site-specific ethics review at each participating institution

Patient and Public Involvement

The platform incorporates patient and public involvement (PPI) throughout:

Trial Design: Patient representatives contributed to endpoint selection and burden assessment

Protocol Review: PPI panel reviewed participant information materials

Governance: Patient advocates participate in trial steering committee

Dissemination: Patient communities will be engaged in result communication

The trial is committed to responsible data sharing:

Summary results will be posted on ClinicalTrials.gov
De-identified participant data may be shared with qualified researchers
Biomarker samples will be stored in biobank for future research
Publications will be open access where possible

Operational Infrastructure

Site Network Development

The EJS ACT-PD platform has established a comprehensive site network:

Comprehensive Movement Disorder Centers:

UCL Queen Square Institute of Neurology, London
Oxford Parkinson's Disease Centre
Cambridge University Hospitals
Newcastle University
University of Edinburgh

Regional District General Hospitals with Research Capacity:

Sites across England, Scotland, Wales, and Northern Ireland
Hub-and-spoke model with centralized expertise

Data Management Systems

The platform employs state-of-the-art data management:

Electronic Data Capture (EDC): Centralized database with real-time validation
Direct Data Capture: Integration with wearable devices and digital assessments
Imaging Repository: Centralized neuroimaging storage and analysis
Biobank Database: Sample tracking and biomarker result integration

Monitoring and Quality Assurance

Rigorous quality assurance ensures data integrity:

Risk-based monitoring strategy
Central statistical monitoring for data quality
Regular site training and certification
Audit program for selected sites

Statistical Framework

Primary Analysis Approach

The statistical framework employs established methods:

Frequentist Framework with Adaptive Elements:

Pre-specified interim analyses at predefined timepoints
Alpha spending function to control overall type I error
Sample size re-estimation capability for promising arms

Multi-arm Comparison:

Control group shared across all treatment arms
Closed testing procedure to control family-wise error rate
Hierarchical testing strategy for primary and key secondary endpoints

Sample Size Considerations

The 1,200 participant sample size provides:

80% power to detect 25% slowing on MDS-UPDRS
Adequate power for multiple arm comparisons
Sufficient sample for subgroup analyses by biomarker status

Missing Data Handling

The analysis plan addresses missing data:

Multiple imputation for intermittent missing data
Sensitivity analyses comparing different assumptions
Pattern mixture models for informative dropout

Current Status and Timeline

Recruitment Progress

As of the latest update:

Status: RECRUITING
Enrollment: 1,200 participants (estimated)
Start date: September 12, 2025
Expected completion: July 31, 2031

Milestones

| Milestone | Expected Date |
|-----------|---------------|
| First patient enrolled | Q4 2025 |
| 25% enrollment | Q2 2026 |
| 50% enrollment | Q4 2026 |
| 75% enrollment | Q2 2027 |
| Primary endpoint analysis | Q3 2029 |
| Final analysis | Q2 2031 |

Future Directions

Expansion Opportunities

The platform is designed for expansion:

International Sites: Expansion to US, European, and other sites planned

New Treatment Arms: Mechanism to add new compounds as they become ready

Substudies: Additional biomarker and imaging substudies can be added

Combination Therapies: Platform can evaluate combination approaches

Integration with Other Platforms

The EJS ACT-PD platform can integrate with:

DIAN-TU: Alzheimer's disease platform trial
PSP Clinical Trial Platform: Tauopathy platform
HEALEY ALS Platform: ALS platform trial
European Platform for Neurodegenerative Disease Research

Long-term Vision

The platform aims to establish a sustainable infrastructure:

Transform PD drug development from sequential to parallel
Create lasting clinical research network
Generate valuable natural history and biomarker data
Establish new standards for neurodegenerative disease clinical trials

Comparison with Other PD Platform Trials

Similar Initiatives

Several platform trials in Parkinson's disease have preceded EJS ACT-PD:

| Platform | Sponsor | Status | Focus |
|----------|---------|--------|-------|
| EJS ACT-PD | UCL | Recruiting | Disease modification |
| PD-STEPS | Michael J. Fox Foundation | Completed | Symptomatic |
| PROSEEK | Various | Completed | Biomarkers |
| PD-MRI | Various | Ongoing | Neuroimaging |

Unique Contributions

EJS ACT-PD contributes uniquely:

Scale: Largest active PD platform trial
Design: Most comprehensive adaptive framework
Integration: Deepest biomarker integration
Duration: Longest follow-up period

Economic Considerations

Cost Efficiency

The platform design provides significant cost advantages:

Shared control group reduces total participants needed
Standardized operations across arms reduce per-site costs
Adaptive design reduces failed trial investments
Biobank and data infrastructure benefit all future research

Resource Utilization

The platform optimizes resource utilization:

Site network maximizes patient access
Centralized data management reduces redundancy
Coordinated sample collection improves efficiency
Standardized assessments enable cross-study comparisons

Impact on PD Research Ecosystem

Training and Capacity Building

The platform contributes to research capacity:

Clinical research training for site staff
Methodology development for platform trials
Data science expertise development
Patient engagement best practices

Collaborative Networks

The platform strengthens collaborative networks:

Academic consortium across UK universities
Industry partnerships for compound provision
Patient organization engagement
International research connections

Conclusion

The Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD) platform trial represents a transformative approach to Parkinson's disease drug development. By enabling simultaneous evaluation of multiple disease-modifying therapies within a rigorous adaptive framework, this platform addresses fundamental inefficiencies in traditional clinical trial designs.

The trial's comprehensive biomarker program, patient-centered design, and regulatory engagement position it to generate high-quality evidence suitable for global regulatory submissions. Beyond evaluating specific treatments, the platform creates lasting infrastructure that will accelerate future PD research and potentially transform the lives of the 10 million people worldwide living with Parkinson's disease.

Results from the EJS ACT-PD platform will be eagerly anticipated by the entire Parkinson's disease community and will inform the next generation of neurodegenerative disease clinical trials.

Clinical Trials

[Clinical Trials Overview](/clinical-trials/overview)
[Drug Development Pipeline](/clinical-trials/drug-pipeline)
[Prasinezumab Phase 3 Trial](/clinical-trials/nct07174310)
[PSP Clinical Trial Platform](/clinical-trials/psp-clinical-trial-platform)

Mechanisms

[Alpha-Synuclein Aggregation](/mechanisms/alpha-synuclein-aggregation)
[Parkinson's Disease Pathogenesis](/mechanisms/parkinsons-pathogenesis)
[Lewy Body Formation](/mechanisms/lewy-body-formation)
[Dopaminergic Neuron Degeneration](/mechanisms/dopaminergic-neuron-degeneration)
[Mitochondrial Dysfunction in PD](/mechanisms/mitochondrial-dysfunction-parkinsons)

Diseases

[Parkinson's Disease](/diseases/parkinsons-disease)
[Parkinson's Disease Subtypes](/diseases/parkinsons-subtypes)
[Parkinson's Disease Dementia](/diseases/parkinsons-disease-dementia)

Proteins

[Alpha-Synuclein](/proteins/alpha-synuclein)
[LRRK2](/genes/lrrk2)
[GBA](/genes/gba)
[Parkin](/proteins/parkin-protein)
[DJ-1](/proteins/dj-1-protein)

Therapeutics

[Disease-Modifying Therapies Overview](/therapeutics/disease-modifying-therapies-overview)
[Alpha-Synuclein-Targeting Therapies](/therapeutics/alpha-synuclein-targeting-therapies)

External Links

[ClinicalTrials.gov Record - NCT07207057](https://clinicaltrials.gov/study/NCT07207057)
[UCL Parkinson's Disease Research](https://www.ucl.ac.uk/neurosurgery/parkinsons-research)
[Parkinson's UK Clinical Trials](https://www.parkinsons.org.uk/research/clinical-trials)
[The Michael J. Fox Foundation for Parkinson's Research](https://www.michaeljfox.org/)
[Parkinson's Foundation](https://www.parkinson.org/)

References

[Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD), ClinicalTrials.gov NCT07207057](https://clinicaltrials.gov/study/NCT07207057)

[Platform trials in neurodegenerative disease: A new paradigm for efficient drug development, Nature Reviews Neurology (2022)](https://doi.org/10.1038/s41582-022-00687-w)

[Parkinson's disease clinical trials 2024: Current landscape and future directions, Movement Disorders (2024)](https://pubmed.ncbi.nlm.nih.gov/38452187/)

[Biomarkers in Parkinson's disease clinical trials, Journal of Parkinson's Disease (2024)](https://doi.org/10.3233/JPD-240202)

[MDS-UPDRS validation in clinical trials, Movement Disorders (2024)](https://doi.org/10.1002/mds.297)

[A Master Protocol Approach to Parkinson's Disease Drug Development, Journal of Parkinson's Disease (2022)](https://doi.org/10.3233/JPD-223541)

[Parkinson's disease biomarkers: Current status and future perspectives, Nature Reviews Neurology (2023)](https://doi.org/10.1038/s41582-023-00800-5)

[Alpha-synuclein seeding and propagation in Parkinson's disease, Nature Reviews Neuroscience (2023)](https://doi.org/10.1038/s41583-023-00735-2)

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📊 Evidence Profile Foundational

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📗 Cite This Artifact

Edmond J Safra Accelerating Clinical Trials in Parkinson's Disease (NCT07207057)

Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD)

Overview

Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease (EJS ACT-PD)

Overview

Trial Details

Platform Trial Design: A Paradigm Shift in PD Drug Development

What is a Platform Trial?

EJS ACT-PD Specific Architecture

Scientific Rationale

The Need for Disease-Modifying Therapies

Platform Trial Advantages for PD

Primary and Secondary Endpoints

Primary Endpoints

Secondary Endpoints

Patient Population and Eligibility

Target Population

Inclusion Criteria (General)

Exclusion Criteria (General)

Participating Sites

UK Sites

Treatment Arms

Expected Therapeutic Approaches

Biomarker Integration

Diagnostic Biomarkers

Prognostic Biomarkers

Pharmacodynamic Biomarkers

Monitoring Biomarkers

Biomarker Types Being Evaluated

Statistical Design

Sample Size Considerations

Adaptive Features

Control Group Design

Clinical Significance

Advancing PD Drug Development

Building PD Research Infrastructure

Impact on the PD Community

Regulatory and Ethics Considerations

Regulatory Engagement

Ethics Approval

Patient and Public Involvement

Data Sharing and Transparency

Operational Infrastructure

Site Network Development

Data Management Systems

Monitoring and Quality Assurance

Statistical Framework

Primary Analysis Approach

Sample Size Considerations

Missing Data Handling

Current Status and Timeline

Recruitment Progress

Milestones

Future Directions

Expansion Opportunities

Integration with Other Platforms

Long-term Vision

Comparison with Other PD Platform Trials

Similar Initiatives

Unique Contributions

Economic Considerations

Cost Efficiency

Resource Utilization

Impact on PD Research Ecosystem

Training and Capacity Building

Collaborative Networks

Conclusion

Related Pages

Clinical Trials

Mechanisms

Diseases

Proteins

Therapeutics

External Links

References

💬 Discussion