News & Resources

The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers

2011 The Alzheimer’s Association, January 2025

The cerebrospinal fluid (CSF) biomarkers amyloid β (Aβ)-42, total-tau (T-tau), and phosphorylated-tau (P-tau) demonstrate good diagnostic accuracy for Alzheimer’s disease(AD). However, there are large variations in biomarker measurements between studies, andbetween and within laboratories. The Alzheimer’s Association has initiated a global qualitycontrol program to estimate and monitor variability of measurements, quantify batch-to-batchassay variations, and identify…

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Lurasidone in Post-menopausal Females With Major Depressive Disorder With Mixed Features–Post-hoc Analysis of a Placebo-Controlled Trial

John Sramek, Antony Loebel, Michael Murphy, Yongcai Mao, Andrei Pikalov, Neal R. Cutler, January 2025

Several studies have found that depressed, post-menopausal females may respond differently toantidepressants compared to pre-menopausal females. The atypical antipsychotic lurasidone, whose mechanism of action differs from SSRIs and other standard antidepressants, was shown in a 6-week randomized, flexibledose, placebo-controlled study (n = 209), to be effective in treating major depressive disorder (MDD) with mixed features…

Read More: Lurasidone in Post-menopausal Females With Major Depressive Disorder With Mixed Features–Post-hoc Analysis of a Placebo-Controlled Trial
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Exploratory Biomarker Study of the Triple Reuptake InhibitorSEP-432 Compared to the Dual Reuptake Inhibitor Duloxetinein Healthy Normal Subjects

John J. Sramek, 1 Larry W. Hardy, 2 Peter Bieck, 1 Cynthia Zamora, 3 Mark Versavel, 2 Jahnavi Kharidia, 2 Todd Grinnell, 2 Yu-Luan Chen, 2 Michael Sullivan, 3 Hong Ding 1 & Neal R. Cutler, January 2025

SEP-432 is a triple monoamine reuptake inhibitor of norepinephrine (NE),serotonin (5-HT), and dopamine (DA), based on invitro binding studies. We sought evidence that SEP-432 engages these monoamine systems by measuring concentrations of monoamines and/or their main metabolites in cerebrospinal fluid (CSF) and plasma and comparing results to duloxetine, a dual reuptake inhibitor of NE and…

Read More: Exploratory Biomarker Study of the Triple Reuptake InhibitorSEP-432 Compared to the Dual Reuptake Inhibitor Duloxetinein Healthy Normal Subjects
Press Mentions Thought Leadership
Balancing Risk and Benefit in Venous Thromboembolism Trials: Concept for a Bivariate Endpoint Trial Design and Analytic Approach

Published in final edited form as: J Thromb Haemost., August 2013

Concept for a Bivariate Endpoint Trial Design and Analytic Approach

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Press Mentions Thought Leadership
Meta-Analysis of Structural Magnetic Resonance Imaging (sMRI) Biomarkers in Schizophrenia Medication Trials

ISCTM 8th Annual Scientific Meeting, February 2012

In order to determine the quality of evidence to support the application of imaging biomarkers in clinical trials of schizophrenia relevant sMRI literature was reviewed. A prior qualitative review following criteria by Altar et al (2008) suggested an evidence rating of “A-/B+” for sMRI in relation to medication effects. In order to provide a more…

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Improving Academic Leadership and Oversight in Large Industry-Sponsored Clinical Trials: The ARO-CRO Model

October 28, 2010

Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, the contract research organization (CRO) that typically assists in executing the trial, regulatory agencies, and academicians, provides inadequate leadership and oversight of the development process….

Read More: Improving Academic Leadership and Oversight in Large Industry-Sponsored Clinical Trials: The ARO-CRO Model
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News & Resources

The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers

Lurasidone in Post-menopausal Females With Major Depressive Disorder With Mixed Features–Post-hoc Analysis of a Placebo-Controlled Trial

Exploratory Biomarker Study of the Triple Reuptake InhibitorSEP-432 Compared to the Dual Reuptake Inhibitor Duloxetinein Healthy Normal Subjects

Balancing Risk and Benefit in Venous Thromboembolism Trials: Concept for a Bivariate Endpoint Trial Design and Analytic Approach

Meta-Analysis of Structural Magnetic Resonance Imaging (sMRI) Biomarkers in Schizophrenia Medication Trials

Improving Academic Leadership and Oversight in Large Industry-Sponsored Clinical Trials: The ARO-CRO Model

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