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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Drug Development
Lieza G Exalto1,2, Siti S Syaziyah3, Xiaotian T Fang1
1Julius Clinical, Zeist, Netherlands.
Background:
Fewer women participate in Alzheimer Disease (AD) trials than expected relative to their estimated representation in the global dementia population. Biotech, pharma, and patient organisations all aim for inclusive and representative trials, mainly focusing on participant engagement and recruitment. We aimed to explore the influence of trial design, by investigating the proportion of men and women presenting at a memory clinic, eligible for trial participation, based on commonly used inclusion criteria.
Method:
Clinical study registration was downloaded from clinicaltrials.gov (2023-09-08) to extract eligibility criteria of 563 phase II and III AD drug trials. A randomly selected 113 (20%) trials were manually annotated by three independent raters. Overall inter-annotator agreement was >0.70 Cohen's Kappa. Next, we applied the top 5 most common criteria in a stepped approach to women and men with a diagnosis of AD or MCI of Alzheimer Center Amsterdam.
Result:
Top 5 most common AD clinical trial eligibility criteria were 1) no other central nervous system (CNS) disorder related to cognition (84%), 2) participation of a caregiver (72%), 3) MMSE (66%; most common 24-30), 4) no contra-indications for study procedures (61%), 5) age (53%; most common 55-85). In the period 2000-2024 in total 3835 patients (48% women) with AD or MCI were seen for a first diagnostic visit at Alzheimer Center Amsterdam. After screening for 1) no other CNS disorder 84% of men and 90% of women remained eligible. Additional screening on 2) participation of caregiver reduces eligibility to 66% of men and 51% of women. 3) MMSE (24-30) reduces eligibility to 35% of men and 18% of women. 4) no contra-indications for study procedures reduces eligibility to 33% of men and 18% of women. Lastly, applying 5) age (55-85) a final 31% of men and 16% of the women remain eligible (table 1).
Conclusion:
Based on commonly used inclusion criteria of clinical trials, women are less likely to be eligible for participation in AD drug trials than men. This discrepancy seems mainly related to lower MMSE at presentation and lack of caregiver presence. These results provide clues for design of trials to be alert for equal inclusion of women.
Insights
Women are less likely to be eligible for Alzheimer
Area of Science:
- Neurology
- Clinical Trials
- Medical Research
Background:
- Alzheimer's Disease (AD) drug trials often lack female participation relative to the global dementia population.
- Industry stakeholders aim for inclusive trials, focusing on engagement and recruitment.
- This study investigates how trial design, specifically eligibility criteria, impacts sex-based participation rates.
Purpose of the Study:
- To analyze the influence of common Alzheimer's Disease clinical trial eligibility criteria on the proportion of men and women eligible for participation.
- To identify specific criteria that disproportionately affect women's eligibility in AD trials.
Main Methods:
- Extracted eligibility criteria from 563 Phase II and III AD drug trials registered on clinicaltrials.gov.
- Manually annotated 113 trials based on the top 5 most common inclusion criteria.
- Applied these criteria sequentially to a cohort of men and women diagnosed with AD or Mild Cognitive Impairment (MCI) at Alzheimer Center Amsterdam.
Main Results:
- The top 5 criteria included: no other central nervous system (CNS) disorder, caregiver participation, Mini-Mental State Examination (MMSE) score range (24-30), no contraindications for study procedures, and age range (55-85).
- Applying these criteria sequentially to 3835 patients (48% women), eligibility decreased significantly for women.
- Final eligibility was 31% for men and 16% for women, primarily due to lower MMSE scores and lack of caregiver availability in women.
Conclusions:
- Commonly used eligibility criteria in Alzheimer's Disease clinical trials result in lower eligibility rates for women compared to men.
- Lower MMSE scores at presentation and reduced caregiver availability appear to be key factors contributing to this discrepancy.
- Trial designs should consider these factors to promote more equitable inclusion of women in AD drug trials.
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