Improve Strategic Study Design
Clinical measurement in preclinical AD presents unique trial challenges. Alzheimer’s disease progresses along a disease continuum with an extended preclinical stage defined by individuals showing amyloid positivity but with normal functional status.
In clinical trials for preclinical AD, the participant characteristics, outcome measures, assessment procedures, and context of assessments require substantially different strategies to those in symptomatic AD. Many scales commonly used to measure cognitive change in other neurodegenerative conditions lack the sensitivity to capture subtle changes associated with preclinical AD so it’s important to carefully consider endpoint approaches.
Cogstate has the hands-on experience to support the unique approaches necessary to reduce patient and site burden and capture quality data in your preclinical AD trial.
Experience Supporting Preclinical AD Trials
Cogstate has substantial experience in preclinical AD, including:
- The only vendor to support central rating of a primary endpoint in a pivotal phase 3 preclinical AD trial.
- Trained hundreds of raters to administer CDR and PACC scales (in addition to other relevant scales) and monitored these assessments to capture and address common administration errors.
- Developed a digital PACC that is validated for in-clinic assessment as well as for remote, administration. Data shared at CTAD, AAIC, and AD/PD highlight the validity, equivalency, and sensitivity.
Cogstate understands your preclinical AD patient population is typically younger, active, and busy. Low-burden and/or at-home testing can increase the likelihood that individuals will participate in trials; these methods can also help address the FDA mandate for increased enrollment of diverse patient populations.
