Read research from Cogstate scientists as presented at industry conferences.

The Cogstate Schizophrenia Battery (CSB) as a Co-Primary Outcome for Trials in Cognitive Impairment Associated with Schizophrenia

Presented at SIRS 2020

Extensive evidence shows cognitive impairment to be a core symptom of schizophrenia that has a negative impact on function. The MATRICS/FDA/NIMH workshop developed guidelines for the design of clinical trials of drugs that could ameliorate cognitive impairment associated with schizophrenia (CIAS). One important consequence was the development of a battery of performance based (PerfO) outcome assessments. The use of the MATRICS Consensus Cognitive Battery (MCCB) as a co primary outcome is recommended by FDA, whilst EMA describe the battery as “acceptable but other, comparable, test batteries may also be used provided their validity is demonstrated”. Following the development an application of the MCCB, substantial concerns have been raised regarding patient and trial burden, and cross-cultural adaptability. In this context, the Cogstate Schizophrenia Battery (CSB) has been developed as a computerized cognitive test battery, meeting consensus requirements, but with significantly reduced burden on patients and clinical trial sites.

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Utility of the Cogstate Brief Battery for In-clinic and At-home Cognitive Assessments in ADNI-3

Presented at AAT-AD/PD 2020

The Cogstate Brief Battery (CBB) is a computerized/digital cognitive test battery assessing psychomotor function, visual attention, visual learning, and working memory. The CBB takes approximately 15 minutes to complete, has been optimized for self-completion, and is offered to cognitively normal (CN) and mild cognitive impairment (MCI) participants in ADNI-3 and those rolling over from ADNI-2. In-clinic visits are completed annually for MCI and every other year for CN participants, with both groups completing unsupervised visits at-home approximately every 3 months.

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Clinical Outcome Assessments for Clinical Trials in Rare Tauopathies

Presented at AAT-AD/PD 2020

Tauopathies may be classified by neuropathological phenotype. Clinically, PSP, CBD, MSA and DLB may be grouped as atypical parkinsonism; FTLD distinguished by behavioral, language and MND variants; and AGD, PART and ARTAG are hard to distinguish from AD. Thus, overlapping measurement concepts exist for clinical outcome assessments (COAs).

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Considerations for the Generalizability of Clinical Outcome Assessment Validation Data Across Rare Diseases

Presented at RARE Patient Advocacy Summit 2019

Development, validation and selection of clinical outcome assessments (COAs) requires, clear understanding of concepts of interest (COIs) for measurement and intended context of use (COU), evidence for content validity and evidence for psychometric validity and reliability. The ability to reuse or adapt existing COAs for novel COUs is valuable in reducing cost and timelines. In rare disease, availability of patients and issues of disease course and severity may make adaptation an imperative.

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Effect of Esketamine Nasal Spray on Cognition in Patients With Treatment-Resistant Depression: Results From Five Phase 3 Studies

Presented at ECNP 2019

Major depressive disorder (MDD) is a debilitating psychiatric illness and is a major contributor to the overall global burden of disease. Nearly one-third of patients with MDD do not respond to available antidepressants (AD) and develop treatment-resistant depression (TRD). The growing prevalence of TRD and the poor response rates to ADs4 , highlight the need for novel treatments that can provide rapid and sustained relief of depressive symptoms in patients with TRD. Esketamine (ESK), the S-enantiomer of ketamine, is an N-methyl-D-aspartate (NMDA) receptor antagonist recently approved by the US FDA as a nasal spray, along with a newly administered oral AD, for therapy of TRD.

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