Over the past two decades, in response to mounting failures, clinical trials of disease-modifying therapies (DMTs) in Alzheimer’s disease (AD) have progressively moved earlier in the disease spectrum to increase the probability of success; today, most Phase III clinical trials enroll patients with “early AD,” commonly comprising mild cognitive impairment (MCI) due to AD (a.k.a. prodromal AD) and mild AD dementia (e.g., MMSE scores ≥ 22). Given the increasing awareness and sensitivity about earlier diagnosis and management of the disease, it is essential to understand how neurologists perceive the performance of current therapies in early patients, especially their expectations for an emerging DMT for early AD on key clinical and nonclinical attributes.

Questions Answered

  • What are the treatment drivers and goals for early AD?
  • Which attributes are key influencers, which have limited impact, and which are hidden opportunities?
  • How do current therapies perform on key treatment drivers and goals for early AD?
  • What are the prevailing areas of unmet need and opportunity in early AD?
  • Based on a conjoint analysis and TPP simulation, what trade-offs between efficacy, safety, and price are neurologists willing to make for a hypothetical new drug for early AD?

Markets covered: United States, United Kingdom, France, and Germany.

Primary Research: Survey of 60 U.S. neurologists and 30 European neurologists.

Key Drugs Covered: donepezil, galantamine, rivastigmine patch, memantine, Namzaric, gantenerumab, BAN2401, elenbecestat.

Key metrics included:

  • Target Product Profile (TPP) simulator based on conjoint analysis methodology.
  • Stated vs. derived importance of product attributes on prescribing behavior.
  • Assessment of current drug performance against treatment drivers and goals.
  • Physician perceptions of unmet needs in the indication and related indications.
  • Analysis of remaining drug development opportunities.

Product Description

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Table of contents

  • Alzheimer's Disease - Unmet Need - Detailed, Expanded Analysis (US&EU) Early Alzheimer's Disease
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products and Regimens for Early AD
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Neurologists' Prescribing Decisions in Early AD
      • Importance of Efficacy Attributes to Prescribing Decisions in Early AD: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Early AD: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Early AD: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Early AD: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Early AD: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Early AD: Europe
      • Key Findings: Stated vs. Derived Importance
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Early AD: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Early AD: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Early AD: United States
      • Overall Performance of Key Therapies for Early AD: Europe
      • Mean Overall Performance of Key Therapies for Early AD: United States and Europe
      • Relative Performance of Key Therapies for Early AD Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Early AD Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Early AD Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Early AD Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Early AD Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Early AD Across Select Convenience of Administration Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Early AD
      • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for Early AD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Neurologists’ Satisfaction with the Performance of Key Therapies for Early AD on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Early AD: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Early AD: Europe
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Early AD: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Early AD: Europe
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Early AD: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Early AD: Europe
      • Key Findings: Unmet Need in AD and Related Indications
      • Surveyed Neurologists' Ascribed Level of Unmet Need in AD and Related Indications: United States
      • Surveyed Neurologists' Ascribed Level of Unmet Need in AD and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Early AD Market and Emerging Therapy Insights
        • Opportunity: A Disease-Modifying Therapy
        • Opportunity: Symptomatic Procognitive Therapies That Are More Effective Than Existing Therapies in the Treatment of Early AD
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
      • Attribute Importance and Part-Worth Utilities
        • Early AD Target Product Profile: Attribute Importance
        • % Less Decline on CDR-SB at 18-24 Months vs. Placebo (primary endpoint): United States
        • % Less Decline on CDR-SB at 18-24 Months vs. Placebo (primary endpoint): Europe
        • % Less Decline on ADAS-cog at 18-24 Months vs. Placebo: United States
        • % Less Decline on ADAS-cog at 18-24 Months vs. Placebo: Europe
        • % Less Conversion of MCI to AD at 18-24 Months vs. Placebo: United States
        • % Less Conversion of MCI to AD at 18-24 Months vs. Placebo: Europe
        • Incidence of ARIA-E (% of patients): United States
        • Incidence of ARIA-E (% of patients): Europe
        • Incidence of Non-Serious AEs (% of patients): United States
        • Incidence of Non-Serious AEs (% of patients): Europe
        • Delivery Profile: United States
        • Delivery Profile: Europe
        • Price per Day: United States
        • Price per Day: Europe
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Early AD Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Early AD Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Early AD Market Simulations: Target Product Profiles Included in Scenario 1
        • Early AD Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Early AD Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Early AD Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Ruchita Kumar, Ph.D

Ruchita has joined as a Lead Analyst in the Central Nervous System and Ophthalmology team at Decision Resources Group.

She comes with eight years of experience in handling various types of commercial assessment projects. She has worked on variety of opportunity assessment and market intelligence projects involving preparation of disease narratives, epi-based forecasts, patent landscapes, social media analysis and building brand performance reports across different therapy areas. She earned a Ph.D. in design and development of modified release dosage forms of anti-diabetic drugs from the University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh.


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