Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trials

Abstract Background Alzheimer’s disease (AD) is a globally prevalent neurodegenerative condition, clinically characterized by progressive memory loss and gradual impairment of cognitive functions. Bapineuzumab is a fully humanized monoclonal antibody that binds to neurotoxic amyloid proteins in the...

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Main Authors: Abdelrahman Ibrahim Abushouk, Ahmed Elmaraezy, Amro Aglan, Reham Salama, Samar Fouda, Rana Fouda, Ammar M. AlSafadi
Format: Article
Language:English
Published: BMC 2017-04-01
Series:BMC Neurology
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12883-017-0850-1
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author Abdelrahman Ibrahim Abushouk
Ahmed Elmaraezy
Amro Aglan
Reham Salama
Samar Fouda
Rana Fouda
Ammar M. AlSafadi
author_facet Abdelrahman Ibrahim Abushouk
Ahmed Elmaraezy
Amro Aglan
Reham Salama
Samar Fouda
Rana Fouda
Ammar M. AlSafadi
author_sort Abdelrahman Ibrahim Abushouk
collection DOAJ
description Abstract Background Alzheimer’s disease (AD) is a globally prevalent neurodegenerative condition, clinically characterized by progressive memory loss and gradual impairment of cognitive functions. Bapineuzumab is a fully humanized monoclonal antibody that binds to neurotoxic amyloid proteins in the brain, enhancing their clearance. We performed this systematic review and meta-analysis to evaluate the safety and efficacy of bapineuzumab in patients with mild to moderate Alzheimer’s disease. Methods We performed a web-based literature search of PubMed, Ovid, EBSCO, Scopus, Embase, Cochrane CENTRAL, and web of science using the relevant keywords. Data were extracted from eligible records and pooled as mean difference (MD) or risk ratio (RR) values with their 95% confidence interval (CI), using Review Manager software (version 5.3 for windows). Heterogeneity was measured by Chi-square and I-square tests. Result The pooled effect estimate from six randomized clinical trials (n = 2380) showed that bapineuzumab significantly reduced the cerebrospinal fluid concentration of phosphorylated tau proteins (Standardized MD = −5.53, 95% CI [−8.29, −2.76]). However, the bapineuzumab group was not superior to the placebo group in terms of change from baseline in Alzheimer’s disease assessment scale (ADAS)-Cog11 (MD = 0.14, 95% CI [−0.72, 0.99]), disability assessment for dementia (DAD) scale (MD = 1.35, 95% CI [−1.74, 4.43]), and mini-mental state examination (MMSE) scores (MD = 0.08, 95% CI [−0.31, 0.47]). Regarding safety, bapineuzumab increased the risk of serious treatment-emergent adverse events (RR = 1.18, 95% CI [1.02, 1.37]) and cerebral vasogenic edema (RR = 40.88, 95% CI [11.94, 135.95]). All bapineuzumab doses (0.15, 0.5, 1, and 2 mg/kg) were similar to placebo in terms of change from baseline in ADAS-cog11, DAD, and MMSE scores, except for the 0.15 mg/kg dose, which caused a significant worsening on the ADAS-cog11 scale (MD = 5.6, 95% CI [0.22, 10.98]). Conclusions Considering the lack of clinical efficacy, combined with the significant association with serious adverse events, bapineuzumab should not be used to treat patients with mild to moderate AD. Future studies should investigate the effect of combining bapineuzumab with other therapeutic strategies and reevaluate the efficacy of targeting amyloid β proteins in AD therapy.
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spelling doaj.art-5046fd6d14404ba3897f6ad82e999eb92022-12-22T03:18:57ZengBMCBMC Neurology1471-23772017-04-0117111310.1186/s12883-017-0850-1Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trialsAbdelrahman Ibrahim Abushouk0Ahmed Elmaraezy1Amro Aglan2Reham Salama3Samar Fouda4Rana Fouda5Ammar M. AlSafadi6Faculty of Medicine, Ain Shams UniversityNovaMed Medical Research AssociationFaculty of Medicine, Tanta UniversityFaculty of Medicine, Benha UniversityFaculty of Medicine, Zagazig UniversityFaculty of Medicine, Zagazig UniversityFaculty of Medicine, Damascus UniversityAbstract Background Alzheimer’s disease (AD) is a globally prevalent neurodegenerative condition, clinically characterized by progressive memory loss and gradual impairment of cognitive functions. Bapineuzumab is a fully humanized monoclonal antibody that binds to neurotoxic amyloid proteins in the brain, enhancing their clearance. We performed this systematic review and meta-analysis to evaluate the safety and efficacy of bapineuzumab in patients with mild to moderate Alzheimer’s disease. Methods We performed a web-based literature search of PubMed, Ovid, EBSCO, Scopus, Embase, Cochrane CENTRAL, and web of science using the relevant keywords. Data were extracted from eligible records and pooled as mean difference (MD) or risk ratio (RR) values with their 95% confidence interval (CI), using Review Manager software (version 5.3 for windows). Heterogeneity was measured by Chi-square and I-square tests. Result The pooled effect estimate from six randomized clinical trials (n = 2380) showed that bapineuzumab significantly reduced the cerebrospinal fluid concentration of phosphorylated tau proteins (Standardized MD = −5.53, 95% CI [−8.29, −2.76]). However, the bapineuzumab group was not superior to the placebo group in terms of change from baseline in Alzheimer’s disease assessment scale (ADAS)-Cog11 (MD = 0.14, 95% CI [−0.72, 0.99]), disability assessment for dementia (DAD) scale (MD = 1.35, 95% CI [−1.74, 4.43]), and mini-mental state examination (MMSE) scores (MD = 0.08, 95% CI [−0.31, 0.47]). Regarding safety, bapineuzumab increased the risk of serious treatment-emergent adverse events (RR = 1.18, 95% CI [1.02, 1.37]) and cerebral vasogenic edema (RR = 40.88, 95% CI [11.94, 135.95]). All bapineuzumab doses (0.15, 0.5, 1, and 2 mg/kg) were similar to placebo in terms of change from baseline in ADAS-cog11, DAD, and MMSE scores, except for the 0.15 mg/kg dose, which caused a significant worsening on the ADAS-cog11 scale (MD = 5.6, 95% CI [0.22, 10.98]). Conclusions Considering the lack of clinical efficacy, combined with the significant association with serious adverse events, bapineuzumab should not be used to treat patients with mild to moderate AD. Future studies should investigate the effect of combining bapineuzumab with other therapeutic strategies and reevaluate the efficacy of targeting amyloid β proteins in AD therapy.http://link.springer.com/article/10.1186/s12883-017-0850-1BapineuzumabPassive immunotherapyAlzheimer’s diseaseDementia
spellingShingle Abdelrahman Ibrahim Abushouk
Ahmed Elmaraezy
Amro Aglan
Reham Salama
Samar Fouda
Rana Fouda
Ammar M. AlSafadi
Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trials
BMC Neurology
Bapineuzumab
Passive immunotherapy
Alzheimer’s disease
Dementia
title Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trials
title_full Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trials
title_fullStr Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trials
title_full_unstemmed Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trials
title_short Bapineuzumab for mild to moderate Alzheimer’s disease: a meta-analysis of randomized controlled trials
title_sort bapineuzumab for mild to moderate alzheimer s disease a meta analysis of randomized controlled trials
topic Bapineuzumab
Passive immunotherapy
Alzheimer’s disease
Dementia
url http://link.springer.com/article/10.1186/s12883-017-0850-1
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