Pharmacological Agents Targeting γ-Secretase Increase Risk of Cancer and Cognitive Decline in Alzheimer’s Disease Patients: A Systematic Review and Meta-Analysis
Abstract
Background: Drugs targeting γ-secretase in Alzheimer’s disease (AD) have failed to demonstrate efficacy in clinical trials. Objective: To perform a meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of drugs targeting γ-secretase in AD. Methods: Ten trials were identified involving 5,227 patients using electronic databases and manual review of reference lists. RCTs of at least two weeks duration involving a drug targeting γ-secretase were eligible. The main outcomes examined were adverse events and cognitive measures (ADAS-cog, MMSE, ADCS-ADL, and CDR-sb). A sub-group analysis was performed, excluding the γ-secretase modulator tarenflurbil, to evaluate the safety and efficacy of γ-secretase inhibitors only. Results: There was an increased risk of adverse events (Odds Ratio (OR) 1.38, 95% CI 1.09–1.73; p = 0.01), serious adverse events (OR 1.50, 95% CI 1.22–1.84; p < 0.001), and skin cancers (OR 4.77, 95% CI 2.83–8.06; p < 0.001). There was significantly increased risk of infections (OR 1.36, 95% CI 1.13–1.63; p < 0.001) in the subgroup analysis excluding tarenflurbil. Pooled results also revealed a worsening in ADAS-cog (difference in means 1.33, 95% CI 0.58–2.08; p < 0.001) and MMSE (difference in means –0.66, 95% CI –0.96 to 0.35; p < 0.001), but not ADCS-ADL or CDR-sb. Conclusion: The use of γ-secretase inhibitors is associated with significantly increased risk of serious adverse events including skin cancers, and worsening in cognitive indicators. This evidence indicates that γ-secretase may not be an appropriate target for clinical treatment of AD.
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Serious safety concerns for γ-secretase inhibitors remove γ-secretase from the role of appropriate target for Alzheimer disease treatment until in-depth studies could help therapeutically target γ-secretase safely.
“Serious safety concerns for γ-secretase inhibitors remove γ-secretase from the role of appropriate target for the treatment of AD43 until in depth studies on this key enzyme could help to therapeutically target γ-secretase in a safe way.44”
From Current and Future Treatments in Alzheimer Disease: An Update (2020) · cites this paper as [43]
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- Authors
- Penninkilampi, R., Brothers, H. M., & Eslick, G. D.
- Affiliations
- The University of Sydney (AU)
- The Ohio State University (US)
- Corresponding author
- Eslick, Guy D.
- Venue
- Journal of Alzheimer’s Disease
- Publisher
- SAGE Publications
- Published
- 2016-07-06
- Volume
- 53
- Issue
- 4
- Pages
- 1395-1404
- ISSN
- 1387-2877 (ISSN-L)
- 1875-8908
- OpenAlex
- W2470499273
- Cited by
- 42
- References
- 38
- Citations by year
- 2026: 2 · 2025: 2 · 2024: 2 · 2023: 3 · 2022: 4 · 2021: 7 · 2020: 8 · 2019: 6 · 2018: 6 · 2017: 1 · 2016: 1
- FWCI
- 0.55
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Alzheimer s Disease (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
- Keywords
- Alzheimer's disease, gamma-secretase inhibitors
- MeSH terms
- Alzheimer Disease, Cognition Disorders, Humans, Neoplasms, Antipsychotic Agents, Randomized Controlled Trials as Topic, Databases, Bibliographic, Amyloid Precursor Protein Secretases
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