Alzheimer’s Disease
and Dementia

Every 3 seconds, someone in the world develops dementia. However, research breakthroughs for slowing Alzheimer’s disease (AD) are gaining momentum. Cogstate has supported 100+ AD studies and can help your team detect even subtle cognitive changes.

We’ve developed the expertise, technology, and operations to optimize the measurements in your studies and invite you to explore how we can help you improve signal detection via clinical and cognitive science expertise, leading endpoint data quality programs, and digital cognitive assessments.

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Improve Strategic Study Design

Cogstate has the expertise and extensive data sets to advise your team on vital study considerations, help you answer key drug development questions, and reduce risk and uncertainty.

Insights from Key Landmark Studies

Cogstate is at the forefront of Alzheimer’s research via participation in several key longitudinal public private partnership (PPP) studies such as secondary prevention trials including A4 and DIAN, as well as registries and natural history studies including AIBL, ADNI, BHR, and the APT Webstudy.

Study Design Guidance from Cognitive Science Experts

Utilizing open data sets made available through our involvement in PPPs, Cogstate scientists can advise study teams on endpoint selection, powering decisions, and interpretation of study results supportive of product efficacy, safety, and differentiating claims.

Go/No-Go Decision-Making Frameworks

A paper in Drug Discovery Today—co-authored by two Cogstate scientists—notes how cognitive data can be used for better Go/No-Go decision-making in Alzheimer’s clinical trials and explores how to apply robust decision-making criteria depending on the specific stage of development, mechanism of action, and design of the trial. Read more.

Implement Robust Endpoint Data Quality Programs

From helping you establish rater qualification criteria, to tailored certification pathways that credit the experience of expert raters, to central monitoring programs that target clinician reviews where they’re needed most, Cogstate supports all aspects of rater training and endpoint data quality programs. Studies also benefit from our global network of 180 highly trained expert clinicians who provide assessment support in 40+ languages.

We have extensive experience with the assessments commonly used in AD trials:

ADAS-Cog, ADCS-ADL, CDR, CIBIC+, DSST, FAQ, GDS, MMSE, NPI, Qol-AD, RAVLT, RBANS, RUD-Lite, Verbal Fluency, and dozens more.

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Leverage Sensitive and Reliable Digital Assessments 

Cogstate digital assessments provide rapid and reliable measurement of distinct domains affected by mild cognitive impairment (MCI), preclinical AD, and mild-to-moderate AD and enable you to capture a complete and nuanced picture of a subject’s cognitive state.

Cogstate tests are culture- and education-neutral and designed for repeated administration with minimal practice or learning effects, making them ideal for use in global clinical trials. Normative data is available for both clinical samples and healthy controls. Study teams can choose the tests that best suit their research questions. Each test has been used in drug trials.

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Sample AD Battery

The tests included are a sample battery based on domains commonly impacted by AD. Final battery recommendations vary based on study needs.

Cogstate Tests:• Detection (Psychomotor Function)
• Identification (Attention)
• One Card Learning (Visual Learning)
• One Back (Working Memory)
• International Shopping List (Verbal Learning)
• International Shopping List - Delayed Recall (Verbal Learning)
• Continuous Paired Associate Learning (Paired Associate Learning)
• Modified Groton Maze Learning (Executive Function)
Length:Between 5-30 minutes
(depending on the number of tests included in the battery)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

Case Examples of Cogstate AD Solutions in Action

FDA Approval for New Alzheimer's Disease Therapeutic Supported by Cogstate

Cogstate managed the endpoint data quality program of all cognitive and clinical outcomes in a global phase 3 trial of an amyloid-lowering drug for patients with early Alzheimer’s disease. To ensure high fidelity measures, the large global trial required a rigorous rater qualification and training program enhanced by central review of ratings by Cogstate’s global network of expert neuropsychologist consultants and senior scientists. The US Food and Drug Administration (FDA) approved the launch of the treatment for marketing.

Patient Selection and Enrollment for Ph 3 Global Alzheimer’s Program

The Cogstate International Shopping List test (ISLT) was used to select appropriate patients for the global Phase 3 MissionAD studies investigating the BACE inhibitor elenbecestat. More than 8,000 adults were screened for entry, and the research team fully enrolled their trials. Data showed the ability of the ISLT to confirm a clinically important memory impairment. (Albala, et al, CTAD 2017) (YouTube Summary)

Support for Proof-of-Concept Evidence Generation

Cogstate digital assessments were used as exploratory efficacy endpoints in a Ph 2 study of PQ912 in Alzheimer’s disease. Data indicated a treatment-related improvement in working memory, helping guide the team into future study questions and considerations regarding the impact of PQ912. (Scheltens et al. Alzheimer’s Research & Therapy (2018) 10:107)

Site Raters Report Highly Positive Alzheimer’s Assessment Training from Cogstate Clinical Expert Coaches

Cogstate sent a survey to 261 English speaking raters trained by Cogstate clinical expert coaches to administer complex Alzheimer’s assessments. 48 individuals responded and gave overwhelmingly positive reviews, with questions on coaches’ competency and feedback receiving 100% positive (Strongly Agree/Agree) responses. (Wacker, et al, AAIC 2022)

Usability and Acceptability of Cogstate Assessments in Remote Settings

A large online registry targeting the assessment of Alzheimer’s disease utilized the Cogstate Brief Battery™. 75,491 participants completed independent, at-home tests every 3-6 months, resulting in extensive baseline (57,000) and longitudinal (28,000) data collection for the study team. Cogstate tests have high usability for the remote assessment of cognition. (Mackin et al. Alzheimers Dement 2018 Jun 21;10:573-582. Nosheny et al. Alzehimers Dement 2018 Oct 15;4:565-574. Weiner et al. Alzheimers Dement 2018 Aug;14(8):1063-1076)

How can we help you optimize the measurement of brain health?

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