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UnknownNCT04937959

Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension

A Study to Evaluate the Ability of Speech- and Language-based Digital Biomarkers to Detect and Characterise Prodromal and Preclinical Alzheimer's Disease in a Clinical Setting - AMYPRED-US PAST Extension Study

Status
Unknown
Phase
Study type
Observational
Enrollment
40 (estimated)
Sponsor
Novoic Limited · Industry
Sex
All
Age
50 Years – 85 Years
Healthy volunteers
Accepted

Summary

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, based on archival spoken or written language samples, as measured by the area under the curve (AUC) of the receiver operating characteristic curve of the binary classifier distinguishing between amyloid positive and amyloid negative arms. Secondary objectives include (1) evaluating how many years before diagnosis of Mild Cognitive Impairment (MCI) such algorithms work, as measured on binary classifier performance of the classifiers trained to classify MCI vs cognitively normal (CN) arms using archival material from the following time bins before MCI diagnosis: 0-5 years, 5-10 years, 10-15 years, 15-20 years, 20-25 years; (2) evaluating at what age such algorithms can detect later amyloid positivity, as measured on binary classifier performance of the classifiers trained to classify amyloid positive vs amyloid negative arms using archival material from the following age bins: younger than 50, 50-55, 55-60, 65-70, 70-75 years old.

Conditions

Timeline

Start date
2021-01-22
Primary completion
2022-08-30
Completion
2022-08-30
First posted
2021-06-24
Last updated
2022-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04937959. Inclusion in this directory is not an endorsement.