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safety
332 studies tagged safety, dated 2000 to 2026-09-09. Bibliography: BibTeX (.bib) · RIS (.ris)
Newest in this topic
Studies
332 studies carry this tag.
Date range
2000 to 2026
Top journals
- Alzheimer's & dementia : the journal of the Alzheimer's Association 26
- Journal of Alzheimer's disease : JAD 21
- The journal of prevention of Alzheimer's disease 20
- Alzheimer's research & therapy 18
- Alzheimer's & dementia (New York, N. Y.) 14
148 journals in all.
Newest first, then by address. Each study has a usefulness score out of 100 (rubric version 4.0); tap a score to see what makes it up. Tags were assigned automatically from each study's title and summary. The same studies as a filter in the library.
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Second-generation anti-amyloid therapies (ATTs) offer new options for early Alzheimer's disease treatment, but with modest efficacy and documented adverse events.
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47/100
Amyloid-related imaging abnormalities (ARIA), side effects of anti-amyloid drugs seen in magnetic resonance imaging of the brain, are a major safety concern in patients with Alzheimer's disease.
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The approvals of the first anti-amyloid antibodies for the treatment of Alzheimer's disease have changed both the clinical and research landscape for the disease.
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During lecanemab treatment for AD, it is essential to fully understand the mechanisms, imaging characteristics, and management strategies of ARIA.
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The TRAILBLAZER-ALZ 6 study (NCT05738486) evaluated the effect of different donanemab dosing regimens on amyloid-related imaging abnormalities with edema/sulcal effusions (ARIA-E).
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Gantenerumab significantly reduced PiB-PET uptake overall and in most regions and showed no changes in FDG-PET or MRI measures.
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Alzheimer's disease (AD) impacts more than half a million people worldwide, with no cure available.
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On 22 May 2025, the Therapeutic Goods Administration (TGA) announced that the anti-amyloid monoclonal antibody donanemab (Eli Lilly, Kisunla) was approved in Australia for the treatment of Alzheimer's disease (AD).
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Monoclonal antibody (mAb) therapies targeting amyloid-beta (Aβ) plaques have gained prominence over the past decade as potential disease-modifying treatments for Alzheimer's disease (AD), leading to major regulatory approvals and global debate.
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Clinical trials for Alzheimer's disease (AD) must be registered on clinicaltrials.gov.
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Fifty-nine RCTs were included. Donanemab and lecanemab ranked among the most effective treatments for improving cognitive function (Clinical Dementia Rating Scale - Sum of Boxes P-scores: 0.88 and 0.77) and daily activities (Alzheimer's Disease Cooperative Study - Activities of Daily Living P-scores: 0.85 and 0.90), based on network meta-analysis findings.
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Four signal calculation methods were used to assess potential adverse reaction signals of lecanemab and aducanumab.
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Between July 2023 and January 2025, 169 patients were screened and 86 initiated lecanemab treatment.
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The emerging class of bispecific antibodies represents a significant advancement in Alzheimer's disease (AD) immunotherapy by addressing the limited brain concentrations achieved with conventional monoclonal antibodies.
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The introduction of anti-amyloid antibodies has ushered in a new era in the treatment of Alzheimer's disease (AD), coinciding with the revision of its diagnostic criteria, which now focus on the biological definition of AD, with amyloid beta at its core.
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Nineteen randomized placebo-controlled trials with 6918 participants were included. rTMS was significantly more effective than placebo/sham stimulation.
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This review considers the use of these mouse models in understanding the mechanisms of Aβ clearance, cerebral amyloid angiopathy (CAA), blood brain barrier breakdown, neuroinflammation, and neuronal dysfunction in response to Aβ immunotherapy.
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The emergence of monoclonal antibody (MABs) drugs since the FDA approval of lecanemab has resulted in dramatic changes in the clinical approach and management of early-stage Alzheimer's disease (AD).
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84/100
Overall, the study drug was well tolerated.
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Subgroup analyses included (i) MCI versus mild AD; (ii) with versus without concomitant AD medications; and (iii) Apolipoprotein E (ApoE4) carriers versus non-carriers.
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Donanemab treatment resulted in earlier and greater AP clearance compared to aducanumab.
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43/100
CAA-ri gains increasing interest as a spontaneous human model of iatrogenic edematous amyloid-related imaging abnormalities (ARIA-E) in the context of amyloid-modifying therapies.
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Monoclonal antibodies (mAbs) have made significant progress in the treatment of Alzheimer's disease (AD).
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These guidelines facilitate the accurate diagnosis and effective management of ARIA; ensure the safe administration of anti-Aβ drugs; and provide a framework for MRI facilities, includes staffing requirements and the use of MRI management systems.
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From an initial sample (N = 2499), 1064 patients (55,000 notes) were reviewed manually (mean age 76 years; 7.3% women; 9.2% Black; 3.9% Hispanic).
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Lecanemab/Donanemab can improve memory, cognitive function, and daily living abilities in patients with early AD, significantly reduce the composite score of Alzheimer's disease, and inhibit the accumulation of amyloid peptides, thereby alleviating symptoms and improving the condition.
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BackgroundAlzheimer's disease (AD) is a growing neurodegenerative disorder causing cognitive decline, memory loss, and functional impairment.
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Alzheimer’s disease (AD) is caused by the build-up of amyloid beta (A$\beta$) proteins in the brain, leading to memory loss and cognitive decline.
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Recent Phase 3 clinical trials have demonstrated its ability to reduce brain amyloid-β (Aβ) load and slow cognitive decline in patients with early Alzheimer's disease (AD).
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This study compared the ADRs of Lecanemab and Aducanumab, revealing that ARIA was the most common AE for both drugs.
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Slowing of cognitive and functional decline, and amyloid reduction in gantenerumab group compared to placebo group were greater in Japanese-GRADUATE than in the global-GRADUATE and JP40959.
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Of 74 participants who were recruited into the OLE study between June 3, 2020, and April 22, 2021, 73 were enrolled and received gantenerumab treatment. 47 (64%) stopped dosing due to early termination of the study by the sponsor, and 13 (18%) prematurely discontinued the study for other reasons; 13 people completed 3 years of treatment.
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Compared with placebo, treatment with mAbs significantly improved cognitive performance on CDR-SB (mean difference -0.25, 95% confidence interval [CI] [-0.38, -0.11]) and ADAS-Cog (standardized mean difference -0.09, 95% CI [-0.12, -0.06]), in which a negative change indicates improvement for both scores.
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Anti-amyloid monoclonal antibodies (MABs) have introduced a new era of Alzheimer's disease (AD) therapeutics with disease-targeted drugs.
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The development of humanized IgG1 anti-amyloid monoclonal antibodies, such as lecanemab, provides a promising novel treatment pathway with potential disease-modifying effects for patients with early Alzheimer's disease (AD).
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This Editorial reviews data on the efficacy and adverse effects of lecanemab amongst individuals with mild Alzheimer disease.
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Lecanemab, a monoclonal antibody targeting β-amyloid protofibrils, has shown promising results in a Phase III clinical trial for the treatment of early stages of Alzheimer's disease (AD) and has been approved by the European Medicines Agency.
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Gantenerumab reduced amyloid PET load, CSF biomarkers of amyloid beta (Aβ)40, total tau (t-tau), phosphorylated tau 181 (p-tau181), neurogranin, S100 calcium-binding protein B (S100B), neurofilament light (NfL), alpha-synuclein (α-syn), neuronal pentraxin-2 (NPTX2), and plasma biomarkers of t-tau, p-tau181, p-tau217, and glial fibrillary acidic protein (GFAP) while increasing plasma Aβ40, Aβ42. vMRI showed increased reduction in whole brain volume and increased ventricular expansion, while hippocampal volume was unaffected.
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Alzheimer's disease (AD) is the most common type of dementia.
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Three monoclonal antibodies directed against specific forms of the amyloid-β (Aβ) peptide have been granted accelerated or traditional approval by the FDA as treatments for Alzheimer disease, representing the first step towards bringing disease-modifying treatments for this disease into clinical practice.
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With full FDA approval and Centers for Medicare & Medicaid Services coverage of lecanemab and donanemab, a growing number of practices are offering anti-amyloid immunotherapy to appropriate patients with cognitive impairment or mild dementia due to amyloid-positive Alzheimer disease.
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Lecanemab may have a significant potential for AEs.
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The overall goal of the Alzheimer's Disease Neuroimaging Initiative (ADNI) is to optimize and validate biomarkers for clinical trials while sharing all data and biofluid samples with the global scientific community.
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Alzheimer's disease, a progressive neurodegenerative pathology, is characterized by the accumulation of Amyloid-β plaques in the brain.
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The so-called "amyloid cascade hypothesis" provides an elegant explanation of Alzheimer's disease (AD), has motivated the amyloid-lowering therapeutic strategy, and led to the elaboration of a rich experimental and conceptual toolkit for the field to progress.
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Symptom-oriented treatment has been the mainstay of Alzheimer disease (AD) pharmacotherapy for decades.
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Amyloid-related imaging abnormalities (ARIA), intracranial signal abnormalities observed in magnetic resonance imaging (MRI), represent one of the main adverse events associated with treating Alzheimer's disease (AD) with anti-amyloid-β (anti-Aβ) monoclonal antibodies.
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Alzheimer's disease (AD) is the most common neurodegenerative disorder, and for providers the term AD is often avoided, favoring generic terms like memory loss or dementia.
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With the advent of the first disease-modifying, anti-amyloid β-directed passive immunotherapy for Alzheimer's disease, questions arise who, when, and how to treat.
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55/100
The Alzheimer's Disease Neuroimaging Initiative (ADNI) Administrative Core oversees and coordinates all ADNI activities, to ensure the success and maximize the impact of ADNI in advancing Alzheimer's disease (AD) research and clinical trials.
From across this tag
9 of the 332 studies in this tag, picked by a fixed rule (a hash of each study's address), not by score or date; each page of this list shows a different 9. The same 9 appear here every time.
- Real-world implementation of lecanemab and donanemab in an Italian memory center: a 1-year experience
- Gantenerumab: an anti-amyloid monoclonal antibody with potential disease-modifying effects in early Alzheimer's disease
- Anti-Aβ Autoantibodies in Amyloid Related Imaging Abnormalities (ARIA): Candidate Biomarker for Immunotherapy in Alzheimer's Disease and Cerebral Amyloid Angiopathy
- Phase II clinical trials of anti-amyloid β antibodies: When is enough, enough?
- Disease Modeling and Model-Based Meta-Analyses to Define a New Direction for a Phase III Program of Gantenerumab in Alzheimer's Disease
- Anti-Amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease
- Safety and efficacy of lecanemab for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials
- First-In-Human safety and long-term exposure data for AAB-003 (PF-05236812) and biomarkers after intravenous infusions of escalating doses in patients with mild to moderate Alzheimer's disease
- An MRI rating scale for amyloid-related imaging abnormalities with edema or effusion