8:50 am Chair’s Opening Remarks

9:00 am Opening Presentation: Treating Alzheimer’s Disease as a Heterogenous Disease

Synopsis

  • Reclassifying Alzheimer’s Disease based on Molecular Mechanisms Based on Targets
  • Refining & Subtyping Alzheimer’s Disease to Stratify Patients for Drug Development & Optimize Treatment
  • Utilising imaging & Fluid biomarkers to identify subtypes of Alzheimer’s Disease
  • Utilizing a range of metrics to identify subtypes of Alzheimer’s Disease into different subcomponents.
  • Determining the co-pathology of Alzheimer’s Disease

Advances in Patient Identification & Stratification

9:30 am Integrating Biomarkers into Trial Design, Patient Selection & Outcome Measures: AgeneBio’s The HOPE4MCI Trial

Synopsis

  • Novel therapeutic targets; hippocampal overactivity driving Alzheimer’s Disease pathology (amyloid deposition, tau progression and cortical atrophy) in patients with amnestic mild cognitive impairment
  • Success Story: AGB101 (low dose levetiracetam) reduces hippocampal overactivity and restores task related episodic memory function in a Phase 2A study in patients with amnestic mild cognitive impairment
  • Clinical Update: HOPE4MCI is a fully enrolled Phase 2B study investigating the effects of AGB101 in patients with mild cognitive impairment due to Alzheimer’s Disease
  • Precision medicine approach to patient selection; strict memory cutoff leads to amyloid positivity which ensures hippocampal overactivity and disease progression
  • Utilization of imaging data (MK-6240 tau PET scans and structural MRI) coupled with the use of blood samples a resource for understanding AD biomarkers and clinical trial outcomes

Advances in Disease Modelling & Biomarkers to Identify Disease Stage & Progression

10:05 am Challenging Differentiated Approach to Neurodegeneration: A Unified Systems Model for Age-Related Neurodegenerative Disease

Synopsis

  • Understanding the journey from healthy to dementia to inform effective therapeutic strategies
  • Unified systems model to derive effective clinical interventions that meets several criteria and offers novel and feasible point of intervention
  • Data providing cell aging as a unified systems model that is within reach
  • Utilizing cell senescence markers to identify neurodegeneration and assess regression in cell dysfunction and cognitive decline

10:25 am Chair Led Q&A

10:45 am Virtual Speed Networking Break

Innovations in Identifying Novel Biomarkers & Maximizing Imaging Biomarkers

11:40 am Panel Discussion: Paradigm Shifting Digital Therapeutics to Treat Alzheimer’s Disease; Utilizing Digital Tools for Disease Modification

Synopsis

  • What are digital therapeutics for disease modification in Alzheimer’s Disease?
  • Evaluating how these next-gen digital therapeutic approaches differ from traditional drugs
  • Addressing clinical endpoints in digital therapeutic studies
  • Understanding how digital therapeutics will affect and potentially transform the neurodegeneration treatment landscape

12:40 pm Dementia, Biomarkers and Biobanks: Applying Proteomics at Population Scale

  • Chris Whelan Associate Director & Head of Translational Genetics, Biogen

Synopsis

  • Applying multiplex proteomics to large-scale databases (e.g. UK Biobank) to identify novel biomarkers of dementia & other complex illnesses
  • Using plasma proteomics to identify neurodegenerative illness pre-clinically (~10 years prior to diagnosis)
  • Advancing disease-specific collaborations across neurology clinics

1:00 pm Virtual Networking Lunch

2:00 pm Use of Novel Biomarkers of P. Gingivalis Infection & Neuroinflammation in the GAIN Trial; An Ongoing Phase 2/3 Clinical Trial Assessing the Activity of Atuzaginstat in Patients with Mild to Moderate Alzheimer’s Disease

  • Leslie Holsinger Executive Vice President of Research & Development, Cortexyme

Synopsis

  • Application of mechanism-specific biomarkers in a trial targeting an infectious pathogen found in the brain of Alzheimer’s patients and tied to neurodegeneration and neuroinflammation
  • Development of novel biomarkers that assess baseline subject characteristics which may be predictive of response
  • Clinical update on baseline biomarker analysis and subject characterization in the GAIN trial with CSF and blood-based biomarkers

2:20 pm Biomarker Strategies to Enable Successful Development of Immuno-Neurology Targets

Synopsis

  • Strategies to discover biomarkers for immuno-neurology targets
  • Integrating PD markers for early dose finding
  • Leveraging biomarkers to establish proof of mechanism and concept

2:40 pm Chair Led Q&A

  • Chris Whelan Associate Director & Head of Translational Genetics, Biogen
  • Leslie Holsinger Executive Vice President of Research & Development, Cortexyme
  • Felix Yeh Head of Biomarkers, Alector

3:00 pm Using Multi-Omics Data to Identify Novel Biomarkers & Biomarker Strategies

Synopsis

  • Non-invasive biomarker approaches to ensure patient comfort
  • Revisiting old biomarkers with new approaches
  • Advances in patient identification and stratification
  • Defining neuroinflammation

3:20 pm Afternoon Virtual Networking

3:40 pm Detection & Quantification of Amyloid Beta Oligomers

Synopsis

  • Utilizing amyloid beta oligomers as both biomarkers and drug targets
  • Highly quantitative detection methods for antibody-based oligomers
  • Demonstrating target engagement for therapeutics for amyloid beta oligomers

4:00 pm Advances in Direct, Functional, Non-Invasive Biomarkers; Athira’s Utilization of ERP P300

Synopsis

  • Adding direct, functional biomarkers to translation and interventional trials to enhance predictiveness for pro-cognitive effects
  • Utilizing highly sensitive latency changes in ERP P300 to monitor cognitive status quantitatively over time
  • Innovation in application of clinically established ERPs; how Athira‘s use of ERP P300 in AD drug development reduces Phase 2 risk
  • Initial interventional RCT results in AD to be presented

4:20 pm Chair Led Q&A

4:40 pm Chair’s Closing Remarks

4:50 pm End of Conference Day One