Lynn D. Kramer
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View article: Combining CSF MTBR‐tau243 and plasma pTau217 ratio enhances the prediction of continuous regional tau PET burden in early Alzheimer's disease
Combining CSF MTBR‐tau243 and plasma pTau217 ratio enhances the prediction of continuous regional tau PET burden in early Alzheimer's disease Open
INTRODUCTION Tau PET informs Alzheimer's disease (AD) staging but is limited by cost and access. Plasma phosphorylated‐to‐nonphosphorylated tau217 ratio (pTau217R) predicts amyloid and tau positron emission tomography (PET), while cerebros…
View article: Multimodal prognostic modeling of individual cognitive trajectories to enhance trial efficiency in preclinical Alzheimer's disease
Multimodal prognostic modeling of individual cognitive trajectories to enhance trial efficiency in preclinical Alzheimer's disease Open
INTRODUCTION Cognitive decline in asymptomatic preclinical Alzheimer's disease (AD) is slow and variable, limiting detection of treatment effects. This study developed models to forecast trajectories and improve trial efficiency. METHODS M…
View article: Response to Xing et al.: post-marketing safety concerns with Lecanemab: a pharmacovigilance study based on the FDA adverse event reporting system database
Response to Xing et al.: post-marketing safety concerns with Lecanemab: a pharmacovigilance study based on the FDA adverse event reporting system database Open
A recent paper published a lecanemab analysis with data from the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. While the authors mention the limitations of FAERS, such as "voluntary (unde…
View article: Predicted natural progression as an Alzheimer's prognostic covariate improves the precision of lecanemab efficacy assessments and clinical trial efficiency
Predicted natural progression as an Alzheimer's prognostic covariate improves the precision of lecanemab efficacy assessments and clinical trial efficiency Open
BACKGROUND Heterogeneity in Alzheimer's disease (AD) progression introduces variability in treatment effect assessments. Using predicted future progression as an AD prognostic covariate (APC) may reduce this variability. This study evaluat…
View article: Is there Evidence for a Continued Benefit for Long‐Term Lecanemab Treatment? A Benefit/Risk Update from Long‐Term Efficacy, Safety and Biomarker Data
Is there Evidence for a Continued Benefit for Long‐Term Lecanemab Treatment? A Benefit/Risk Update from Long‐Term Efficacy, Safety and Biomarker Data Open
Lecanemab, a humanized IgG1 monoclonal antibody that binds with high affinity to amyloid‐beta (Aβ) protofibrils, was formally evaluated as a treatment for early Alzheimer’s disease in a phase 2 study (Study 201) and the phase 3 Clarity AD …
View article: Prediction of regional brain tau levels in early Alzheimer’s disease using plasma pTau217
Prediction of regional brain tau levels in early Alzheimer’s disease using plasma pTau217 Open
Background PET quantification of brain tau pathology aids in Alzheimer’s disease staging and patient screening. This study assesses whether the phosphorylated to nonphosphorylated plasma Tau217 ratio (pTau217R) predicts regional tau PET st…
View article: How Does the Latest Clinical Pharmacology Data & Modeling Support Continued Lecanemab Dosing?
How Does the Latest Clinical Pharmacology Data & Modeling Support Continued Lecanemab Dosing? Open
Lecanemab is a humanized IgG1 monoclonal antibody binding with high affinity to protofibrils of amyloid‐beta (Aβ) protein. In 18‐month clinical studies, lecanemab has been shown to reduce a complex group of protein interactions associated …
View article: Does the Current Evidence for Lecanemab Mechanism Support a Rationale for Continued Lecanemab Dosing?
Does the Current Evidence for Lecanemab Mechanism Support a Rationale for Continued Lecanemab Dosing? Open
Alzheimer’s disease pathophysiology is believed to involve various abnormalities, including those of amyloid beta (Ab) peptide and tau processing, inflammation, oxidative stress, and vascular risk factors. Aβ peptides exist in a dynamic co…
View article: Lecanemab Slows Amyloid‐Induced Tau Pathology as Supported by CSF MTBR‐tau243 in Clarity AD
Lecanemab Slows Amyloid‐Induced Tau Pathology as Supported by CSF MTBR‐tau243 in Clarity AD Open
Background Lecanemab is a humanized immunoglobulin G1 monoclonal antibody targeting neurotoxic Aβ protofibrils and Aβ plaques, which reduces markers of amyloid and significantly slows clinical decline on multiple cognition and function mea…
View article: Plasma pTau217 ratio predicts continuous regional brain tau accumulation in amyloid‐positive early Alzheimer's disease
Plasma pTau217 ratio predicts continuous regional brain tau accumulation in amyloid‐positive early Alzheimer's disease Open
BACKGROUND This study examines whether phosphorylated plasma Tau217 ratio (pTau217R) can predict tau accumulation in different brain regions, as measured by positron emission tomography (PET) standardized uptake value ratio (SUVR), for sta…
View article: Correction: Updated safety results from phase 3 lecanemab study in early Alzheimer’s disease
Correction: Updated safety results from phase 3 lecanemab study in early Alzheimer’s disease Open
View article: Plasma pTau181 enhances the prediction of future clinical decline in amyloid‐positive mild cognitive impairment
Plasma pTau181 enhances the prediction of future clinical decline in amyloid‐positive mild cognitive impairment Open
Plasma pTau181, a marker of amyloid and tau burden, was evaluated as a prognostic predictor of clinical decline and Alzheimer's disease (AD) progression of amyloid‐positive (Aβ+) patients with mild cognitive impairment (MCI). The training …
View article: Plasma pTau217 predicts continuous brain amyloid levels in preclinical and early Alzheimer's disease
Plasma pTau217 predicts continuous brain amyloid levels in preclinical and early Alzheimer's disease Open
BACKGROUND This study investigated the potential of phosphorylated plasma Tau217 ratio (pTau217R) and plasma amyloid beta (Aβ) 42/Aβ40 in predicting brain amyloid levels measured by positron emission tomography (PET) Centiloid (CL) for Alz…
View article: Clinical Meaningfulness in Alzheimer's Disease Clinical Trials. A Report from the EU-US CTAD Task Force
Clinical Meaningfulness in Alzheimer's Disease Clinical Trials. A Report from the EU-US CTAD Task Force Open
Recent positive results of three phase III anti-amyloid monoclonal antibody trials are transforming the landscape of disease-modifying therapeutics for Alzheimer's disease, following several decades of failures. Indeed, all three trials ha…
View article: Updated safety results from phase 3 lecanemab study in early Alzheimer’s disease
Updated safety results from phase 3 lecanemab study in early Alzheimer’s disease Open
View article: Predicting clinical progression trajectories of early Alzheimer's disease patients
Predicting clinical progression trajectories of early Alzheimer's disease patients Open
BACKGROUND Models for forecasting individual clinical progression trajectories in early Alzheimer's disease (AD) are needed for optimizing clinical studies and patient monitoring. METHODS Prediction models were constructed using a clinical…
View article: Prognostic prediction of the longitudinal cognitive trajectory of amyloid‐positive patients with mild dementia
Prognostic prediction of the longitudinal cognitive trajectory of amyloid‐positive patients with mild dementia Open
Background Prediction of longitudinal cognitive decline for patients with mild dementia using baseline characteristics will be useful for designing optimal clinical trials and real‐world patient monitoring. This can be accomplished via mac…
View article: Detection of brain Tau deposition across Braak stages using plasma pTau181, MRI, and cognitive function assessments
Detection of brain Tau deposition across Braak stages using plasma pTau181, MRI, and cognitive function assessments Open
Background Non‐invasive methods for detecting neurofibrillary tangles that spread throughout the brain are needed for efficiently screening patients in Alzheimer’s disease (AD) clinical trials. This can be accomplished via machine‐learning…
View article: Eligibility Rates among Racially and Ethnically Diverse <scp>US</scp> Participants in Phase 2 and Phase 3 Placebo‐Controlled, Double‐Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease
Eligibility Rates among Racially and Ethnically Diverse <span>US</span> Participants in Phase 2 and Phase 3 Placebo‐Controlled, Double‐Blind, Randomized Trials of Lecanemab and Elenbecestat in Early Alzheimer Disease Open
Objective Many factors contribute to inadequate diversity in Alzheimer disease (AD) clinical trials. We evaluated eligibility rates among racial and ethnic groups at US sites in large global multisite trials in early AD. Methods Using scre…
View article: Lecanemab for Patients With Early Alzheimer Disease
Lecanemab for Patients With Early Alzheimer Disease Open
Importance Bayesian clinical trial designs are increasingly common; given their promotion by the US Food and Drug Administration, the future use of the bayesian approach will only continue to increase. Innovations possible when using the b…
View article: ARIA in patients treated with lecanemab (BAN2401) in a phase 2 study in early Alzheimer's disease
ARIA in patients treated with lecanemab (BAN2401) in a phase 2 study in early Alzheimer's disease Open
INTRODUCTION Lecanemab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that preferentially targets soluble aggregated Aβ species (protofibrils) with activity at amyloid plaques. Amyloid‐related imaging abnormalities (ARIA) prof…
View article: Lecanemab in patients with early Alzheimer’s disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study
Lecanemab in patients with early Alzheimer’s disease: detailed results on biomarker, cognitive, and clinical effects from the randomized and open-label extension of the phase 2 proof-of-concept study Open
View article: Consistency of efficacy results across various clinical measures and statistical methods in the lecanemab phase 2 trial of early Alzheimer’s disease
Consistency of efficacy results across various clinical measures and statistical methods in the lecanemab phase 2 trial of early Alzheimer’s disease Open
View article: Lecanemab in Early Alzheimer’s Disease
Lecanemab in Early Alzheimer’s Disease Open
Lecanemab reduced markers of amyloid in early Alzheimer's disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events. Longer trials are warranted t…
View article: Time to exceed pre‐randomization monthly seizure count for perampanel in participants with primary generalized tonic–clonic seizures: A potential clinical end point
Time to exceed pre‐randomization monthly seizure count for perampanel in participants with primary generalized tonic–clonic seizures: A potential clinical end point Open
Objective To evaluate the exploratory time to exceed pre‐randomization seizure count (T‐PSC) in the determination of efficacy of adjunctive perampanel in participants with primary generalized tonic–clonic (PGTC) seizures in generalized‐ons…
View article: The AHEAD 3‐45 Study: Design of a prevention trial for Alzheimer's disease
The AHEAD 3‐45 Study: Design of a prevention trial for Alzheimer's disease Open
Introduction The Alzheimer's disease (AD) continuum begins with a long asymptomatic or preclinical stage, during which amyloid beta (Aβ) is accumulating for more than a decade prior to widespread cortical tauopathy, neurodegeneration, and …
View article: Correction: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody
Correction: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody Open
View article: Baseline characteristics for CLARITY AD: A phase 3 placebo‐controlled, double‐blind, parallel‐group, 18‐month study evaluating lecanemab (ban2401) in early Alzheimer's disease
Baseline characteristics for CLARITY AD: A phase 3 placebo‐controlled, double‐blind, parallel‐group, 18‐month study evaluating lecanemab (ban2401) in early Alzheimer's disease Open
Background Lecanemab (BAN2401) is a humanized IgG1 monoclonal antibody that preferentially targets soluble aggregated Aβ. In a recent multinational, phase 2, double‐blind, placebo‐controlled, study utilizing a Bayesian design with response…
View article: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody
A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody Open
View article: AHEAD 3‐45 study design: A global study to evaluate the efficacy and safety of treatment with BAN2401 for 216 weeks in preclinical Alzheimer’s disease with intermediate amyloid (A3 trial) and elevated amyloid (A45 trial)
AHEAD 3‐45 study design: A global study to evaluate the efficacy and safety of treatment with BAN2401 for 216 weeks in preclinical Alzheimer’s disease with intermediate amyloid (A3 trial) and elevated amyloid (A45 trial) Open
Background Aβ pathologies occur years prior to cortical tauopathy, neurodegeneration, and clinical symptoms. BAN2401 is a humanized immunoglobulin G1 monoclonal antibody that selectively binds to soluble Aβ aggregated species (oligomers, p…