ki:e SB-C biomarker

As pre-screening tool in prodromal AD

Challenges to clinical trials

Clinical trial recruitment poses significant challenges to drug development

80%

of trails fail to meet enrollment timelines

30%

of clinical trial's timeline is spent on patient recruitment

$5.9B

spent annually on clinical trial recruitment

5%

or less of potential candidates enrolled in clinical trials

Reference: Johnson, Tesheia, et al. Using research metrics to improve timelines: proceedings from the 2nd Annual CTSA Clinical Research Management Workshop.Clinical and translational science 3.6 (2010): 305-308. Ali, Z., Zibert, J. R., & Thomsen, S. F. (2020). Virtual clinical trials, Dermatology, 236(4), 375-382. Bielski, R. J., & Lydiard, R. B. (1997). Therapeutic trial participants: where do we find them and what does it cost?. Psychopharmacology bulletin, 33(1), 75.

Enrollment duration as key barrier for AD trials

AD trials take longer time than trials of other disease areas

Average trial durations in years

Reference: Goldman, D. (2020). Key Barriers for Clinical Trials for Alzheimer’s Disease. USC Schaeffer Center White Paper, Aug, 17.

Using ki:e SB-C for pre-screening will significantly lower the enrollment duration.

Speed up enrollment process

Pre-screening using ki:e SB-C biomarker

Using ki:e SB-C will significantly reduce the number of candidates invited to sites for screening and improve successful screen-in rate.

Validity of the ki:e SB-C biomarker

Under the hood of pre-screening — psychometric properties of ki:e SB-C

correlation with the MMSE

Strong correlation of the ki:e SB-C biomarker with MMSE total score.

discriminating between stages

Significant group differences between Dementia, MCI and HC.

ki:e SB-C performance in a retrospective example study​

Real world numbers of the ki:e SB-C in pre-screening including early AD

Using a study-customised referral engine for the inclusion of early AD on top of the ki:e sb-c, the ki:elements solution performs significantly better compared to the MMSE.

MMSE

ki:e SB-C

Use case of ki:e as pre-screening tool in the screening roadmap

Integration into existing remote CRO screening funnel

Using the ki:e fully automated phone bot prescreening fits seamlessly into CRO screening funnels. Participants perform three speech tasks on the 15 minutes fully automated phone call. The speech is automatically analysed and based on the inclusion and exclusion criteria of the study ki:e returns referral decision (true/false) to the CRO system.

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