Momentum in Alzheimer’s Disease Research | Scientific and Operational Advancements in Clinical Trials
Alzheimer’s disease (AD) research has gained momentum with an enormous scope of advancement being seen in clinical trials, notes Aaron Vederman, PhD, a neuropsychologist working on clinical trials in this space. In this summary of the 2022 CTAD event, he notes changes both in terms of basic science as well as evolving methodologies in research and operational efficiencies.
When a Parkinson’s disease (PD) diagnosis is made, the focus is often on the cardinal motor symptoms. However, there are a number of important non-motor symptoms that accompany the disease, including cognitive impairment.
The ability to create patient-centric, rapid-to-enroll clinical trials is more important now than ever. Biopharma teams are adopting decentralized models to meet these needs. One decentralized practice that is being utilized by more and more teams for its ability to improve data quality and reduce patient and site burden is Central Rating.
Clinical meaningfulness refers to both the measurement of concepts of interest which are relevant for patients and to treatment effects which are sufficiently large, such they confer clinical benefit for patients. Determining whether an Alzheimer’s Disease intervention is clinically meaningful is a challenge still unsolved. Read two recent papers summarizing ideas on establishing these frameworks.
Behavioral and Biological Markers in Rare Disease Research: Tandem Approach Increases Sensitivity and Specificity
Clinical trial teams are seeking to increase sensitivity and specificity in their rare disease research by developing indication-specific behavioral measures and leveraging biological markers of treatment response.
April is Parkinson’s Awareness Month. We sat down with Dr. Lisle Kingery, Clinical Science Director at Cogstate, to discuss his experience and research interest in this area, as well as the various ways Cogstate are supporting accurate and sensitive clinical assessments in Parkinson’s disease Clinical Trials.
A New Clinical Global Impression Scale Enables Precise Detection of Severity and Improvement in Angelman Syndrome
The CGI-S/-I-AS is a recently created adapted rating scale that specifically quantifies symptoms in Angelman syndrome. Published data describes in detail the systematic 5-step process that resulted in the development and validation of the scale. When implemented along with rigorous training and calibration, this new reliable scale will positively impact AS clinical trials, as it can reliably assess treatment efficacy.
Clinical Dementia Rating–Sum of Boxes: A Promising Outcome Measure for Improved Sensitivity to Treatment Efficacy in Future AD Clinical Trials
A recent study evaluated the psychometrics of several cognitive and functional assessments used in prodromal Alzheimer’s disease clinical trial populations. A key finding was that the CDR-SB shows sensitivity to detect impairment and change in patients with pAD, confirming the importance of this assessment for clinical trials in this space. Read more about the data and implications.
Researchers Share Cognitive Go/No-Go Decision-Making Criteria for Alzheimer’s Disease Drug Development
Clear Go/No-Go decisions must be made at key points during the Alzheimer’s disease (AD) drug-development process. The earlier a compound is terminated, the sooner resources can be reallocated to something more promising. Unfortunately, most AD drugs that have progressed to late-stage clinical trials have failed, suggesting that effective Go/No-Go decision making in early-phase clinical trials remains a costly and common challenge for AD drug developers.
The under-representation of racial minorities in clinical trials is an issue facing our industry. One small step in addressing this Is understanding preferences of minority patient populations. A group of American researchers who focus on aging issues sought to gather the opinions of Black, older adults on both a traditional, paper-and-pencil neuropsychological test battery and two computerized cognitive batteries, including the Cogstate Brief Battery (CBB).
Research Shows Exercise Has Positive Effects on Cognition in Veterans with Depression and BDNF Val66Met Mutation
A recent study, published in the American Journal of Geriatric Psychiatry, compared the cognitive health of veterans with and without depression alongside their reported level of physical activity and the presence of a variation to a genetic protein known to improve brain plasticity. The study data was gathered from 1,386 U.S. military veterans over the age of 50; each took a web-based survey that included the Cogstate Brief Battery.
Study Links Repetitive Head Impacts and Traumatic Brain Injury with Depression and Cognitive Dysfunction
New research reinforces the relationship between repetitive head impacts, traumatic brain injury and neurological dysfunction later in life. While a logical link exists, this most recent study provides insight into not only cognitive challenges, but also the onset of depression as a result of experience with contact sports, physical abuse or military service.
A4 Study Baseline Data Show C3 Computerized Battery has Potential as Proxy for Paper and Pencil Measures in AD Prevention Trials
Results from the A4 study baseline assessments have identified that the Computerized Cognitive Composite (C3) battery has potential to serve as a proxy for paper and pencil measures in AD prevention trials. Cogstate’s CSO sat down with Dr. Kate Papp, the lead author of a recent publication showcasing C3 data.
AHRQ Systematic Review Classifies Cogstate Cognitive Tests as Highly Sensitive and Specific in Distinguishing Alzheimer’s Disease
A recent review of the cognitive tests available for identifying impairment related to Alzheimer’s disease and its very early stages ranked both the Cogstate Brief Battery (CBB) and the Cogstate International Shopping List Test in the highest bracket for sensitivity and specificity at distinguishing CATD from normal cognition.
Study Shows Scopolamine Challenge Test May be a Viable Screening Tool for Aβ-related Cognitive Decline in Preclinical Alzheimer’s Disease
While PET scanning will remain important, the scopolamine challenge test (SCT) may offer another method for understanding early AD related changes in people at risk for the disease.