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AD and its comorbidities: An obstacle to develop a clinically efficient treatment?
1Dementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.
Alzheimer's disease (AD) treatments face challenges due to comorbidities often excluded from trials. Adapting clinical trials to include these conditions is crucial for developing effective AD therapies.
Area of Science:
- Neuroscience
- Pharmacology
- Clinical Trials
Background:
- Alzheimer's disease (AD) lacks treatments proven to slow progression.
- Regulatory divergence (FDA vs. EMA) on aducanumab highlights efficacy and safety concerns.
- Comorbidities are common in AD patients but often excluded from clinical trials.
Purpose of the Study:
- To discuss the impact of comorbidities on Alzheimer's disease (AD) treatment development.
- To examine evolving definitions of AD and common comorbid conditions.
- To analyze how comorbidity exclusion/inclusion affects AD trials and real-world therapeutic use.
Main Methods:
- Literature review and discussion of AD definitions and comorbidities.
- Analysis of the implications of comorbidity exclusion in clinical trials.
- Examination of the impact of comorbidities on the real-world application of AD therapeutics.
Main Results:
- Definitions of Alzheimer's disease (AD) continue to evolve.
- Several comorbidities frequently accompany or mimic AD.
- Exclusion of comorbidities from trials may limit the generalizability of treatment efficacy and safety findings.
Conclusions:
- Comorbidities significantly complicate Alzheimer's disease (AD) treatment development.
- Clinical trial designs may need adaptation to better reflect the complexities of AD patients.
- Future research should consider the impact of comorbidities for more effective AD therapeutics.
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