Advancing Toward Regulatory-Grade Clinical Evidence

APOLLO II is our ongoing retrospective, multi-center clinical validation study designed to support future regulatory submissions for its blood-based predictive tests in Alzheimer’s disease.

The study is designed to validate our proprietary multiomics algorithms for predicting progression to Alzheimer’s dementia symptoms using plasma samples from individuals with long-term clinical follow-up. It includes more than 20 cohorts across 11 countries, with approximately 1,100 individuals for B-HEALED and 2,500 individuals for B-AHEAD.

For B-HEALED, APOLLO II focuses on individuals with mild cognitive impairment or mild dementia at baseline, comparing those who progressed to Alzheimer’s dementia with those who progressed to other brain disorders. For B-AHEAD, the study focuses on cognitively unimpaired individuals at baseline, comparing those who progressed to Alzheimer’s dementia with those who progressed to other brain disorders or remained cognitively healthy during follow-up.

By validating both tests across large, independent, longitudinal cohorts, APOLLO II is designed to strengthen the clinical evidence supporting blood-based prediction of Alzheimer’s dementia progression.