Participation in digital cognitive test, biomarker assays linked to AD study enrollment
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Key takeaways:
- Researchers assessed 201 individuals with a digital cognitive test and blood-based biomarkers for Alzheimer’s pathology.
- Participation in both tests was strongly correlated with enrollment in clinical trials.
Participation in memory-based digital cognitive testing and blood-based biomarker assays for Alzheimer’s-related pathology was linked to successful enrollment into clinical trials for disease-modifying treatment, according to research.
“Clinical trials for Alzheimer’s has long sought a quick digital test for screening participants for clinical trials leading to successful randomizations,” David Watson, PsyD, founder of the Alzheimer’s Research and Treatment Center in Florida, said in his poster presentation at CTAD.
Watson and colleagues sought to examine the efficacy of MEMtest, a 10-minute digital cognitive test developed to identify patients with memory problems who may or may not be suited for enrollment in AD-based clinical trials.
Their assessment included 201 participants (mean age 70 years; 61.2% female) recruited through various media, database and referrals. All individuals completed the MEMtest at baseline prior to attending a clinic appointment at ARTC. Within 2 weeks, all participants underwent a detailed clinical assessment, with blood samples collected per International Classification of Functioning, Disability and Health (ICF) guidelines.
A diagnosis of Unimpaired/AAMI (Age-Associated Memory Impairment; n = 106) or Impaired (mild cognitive impairment/mild AD; n = 95) was made based upon a 90-minute in-person evaluation by the ARTC clinical team.
All participants were followed through randomization into disease-modifying therapy trials, and their plasma samples were batch shipped to C2N Diagnostics for mass spectrometry-based analysis of biomarkers A42/40, p-tau217/np-tau217 and APS2 via the PrecivityAD2 blood test for AD pathology assessment.
Primary endpoints for the evaluation were MEMtest correlation with Rey Auditory Verbal Learning Test (RAVLT) and cognitive status based on a detailed neurocognitive assessment, with secondary endpoints including MEMtest correlation with brain amyloid and enrollment into a future DMT trial across the clinical disease spectrum.
Results showed that as of September, 186 participants had a PrecivityAD blood test evaluation, while 28 of 201 participants were successfully randomized into a DMT study.
Analysis found that submitting to the MEMtest and the PrecivityAD2 blood test was correlated with DMT randomization, with the MEMtest also having statistically significant correlation to the PrecivityAD2 blood test result.
“MEMtest combined with a high accuracy tool like the PrecivityAD2 blood test to identify [Alzheimer’s disease] pathology has potential for use in the population help create trial-ready cohorts,” Watson wrote.