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Unveiling Gaps and Demographic Influences in Alzheimer's Therapy: A Data-Centric Study of FDA-Approved Late-Phase Clinical Trials.

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Title: Unveiling Gaps and Demographic Influences in Alzheimer's Therapy: A Data-Centric Study of FDA-Approved Late-Phase Clinical Trials.
Authors: Kalokhe, Vaishnavi Milind (AUTHOR), Simran, Simran (AUTHOR), Ahmad, Aftab (AUTHOR), Musthafa, Fathima (AUTHOR), Gangawane, Vishal Sachin (AUTHOR), Raghuvanshi, Rajeev Singh (AUTHOR), Srivastava, Saurabh (AUTHOR)
Source: Neurological Sciences. Jul2025, Vol. 46 Issue 7, p3085-3095. 11p.
Subjects: Alzheimer's disease, Clinical trials, Databases, Gender, Placebos
Abstract: Background: Alzheimer's disease is more prevalent in women than in men. In this study, the author examined the U.S. Food and Drug Administration (FDA) completed phase 4 clinical trials associated with Alzheimer's. The research aims to evaluate the women's participation-to-prevalence ratio (PPR) for Alzheimer's disease. Method: Using the FDA's publicly available clinical trial database, 45 Phase 4 Alzheimer's trials from 2003 to 2019 were assessed. Further, the total PPR and yearly PPR value are calculated by dividing the percentage of women in clinical trials by the total percentage of women affected by Alzheimer's disease. The PPR value equal to 1 showcases the balanced participation of females in the Phase 4 clinical trial and the diseased affected population. Result: Out of 45 trials, 41 were completed and four were terminated. The gender data was unavailable for three trials. In 38 clinical trials associated with Alzheimer's disease, 4502 participants were enrolled. Among 4502, 2604 (57.84%) were found to be female and 1898 (42.15%) were male. The PPR for women was 0.80, reflecting an adequate representation of women participants in late-phase clinical trials. The yearly PPR reduction has been seen in female participants. Conclusion: In the year-based PPR, the range was from 0.72–1.0. In the initial year, the range was 1, which was reduced to 0.72 in 2007. In total, 38 completed clinical trials, 18 trials used placebo treatment, and the gender ratio in placebo was adequate. More transparency is essential in gender concerning SAE in publicly available databases. [ABSTRACT FROM AUTHOR]
Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Unveiling Gaps and Demographic Influences in Alzheimer's Therapy: A Data-Centric Study of FDA-Approved Late-Phase Clinical Trials.
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  Data: <searchLink fieldCode="AR" term="%22Kalokhe%2C+Vaishnavi+Milind%22">Kalokhe, Vaishnavi Milind</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Simran%2C+Simran%22">Simran, Simran</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Ahmad%2C+Aftab%22">Ahmad, Aftab</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Musthafa%2C+Fathima%22">Musthafa, Fathima</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Gangawane%2C+Vishal+Sachin%22">Gangawane, Vishal Sachin</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Raghuvanshi%2C+Rajeev+Singh%22">Raghuvanshi, Rajeev Singh</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Srivastava%2C+Saurabh%22">Srivastava, Saurabh</searchLink> (AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Neurological+Sciences%22">Neurological Sciences</searchLink>. Jul2025, Vol. 46 Issue 7, p3085-3095. 11p.
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  Data: <searchLink fieldCode="DE" term="%22Alzheimer's+disease%22">Alzheimer's disease</searchLink><br /><searchLink fieldCode="DE" term="%22Clinical+trials%22">Clinical trials</searchLink><br /><searchLink fieldCode="DE" term="%22Databases%22">Databases</searchLink><br /><searchLink fieldCode="DE" term="%22Gender%22">Gender</searchLink><br /><searchLink fieldCode="DE" term="%22Placebos%22">Placebos</searchLink>
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  Data: Background: Alzheimer's disease is more prevalent in women than in men. In this study, the author examined the U.S. Food and Drug Administration (FDA) completed phase 4 clinical trials associated with Alzheimer's. The research aims to evaluate the women's participation-to-prevalence ratio (PPR) for Alzheimer's disease. Method: Using the FDA's publicly available clinical trial database, 45 Phase 4 Alzheimer's trials from 2003 to 2019 were assessed. Further, the total PPR and yearly PPR value are calculated by dividing the percentage of women in clinical trials by the total percentage of women affected by Alzheimer's disease. The PPR value equal to 1 showcases the balanced participation of females in the Phase 4 clinical trial and the diseased affected population. Result: Out of 45 trials, 41 were completed and four were terminated. The gender data was unavailable for three trials. In 38 clinical trials associated with Alzheimer's disease, 4502 participants were enrolled. Among 4502, 2604 (57.84%) were found to be female and 1898 (42.15%) were male. The PPR for women was 0.80, reflecting an adequate representation of women participants in late-phase clinical trials. The yearly PPR reduction has been seen in female participants. Conclusion: In the year-based PPR, the range was from 0.72–1.0. In the initial year, the range was 1, which was reduced to 0.72 in 2007. In total, 38 completed clinical trials, 18 trials used placebo treatment, and the gender ratio in placebo was adequate. More transparency is essential in gender concerning SAE in publicly available databases. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Neurological Sciences is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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              Text: Jul2025
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