AMYPRED Pilot Trial - Stage 1
Research type
Research Study
Full title
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.
IRAS ID
281074
Contact name
Emil Fristed
Contact email
Sponsor organisation
Novoic Ltd
Duration of Study in the UK
0 years, 3 months, 10 days
Research summary
The purpose of the AMYPRED study is to evaluate, in a clinical setting, the ability of speech and language based digital biomarkers to detect and characterise early stages of Alzheimer’s disease.
Participants in the AMYPRED trial will be enrolled into four cross-sectional cohorts depending on their previous cognitive and biomarker status.
The PRESENT study will consist of a battery of neuropsychological tests (CDR, ADAS-Cog, MMSE), as well as a speech-based battery structured into the patient-clinician conversation. After consent, all conversations during assessments will be recorded and analyzed on Novoic’s technology platform. The speech scores of Novoic’s technology platform will be validated against the participant’s biomarker status and scores on the taken cognitive assessments - that are together the gold-standard measures of diagnosing Alzheimer’s disease clinically
FUTURE extension study: patients enrolling in the FUTURE study will come into the same site for a follow up visit after 6 months. Here the same battery of tests will be performed as in the first visit. In the 6 months between the two visits patients will be offered access to a mobile application, where they can complete speech tests remotely. How often these are completed are subject to the patient. This part of the FUTURE extension is optional.
PAST extension study: patients enrolling in the PAST study will be asked to submit spoken and written material from themselves, recorded/written in the past. This could include e.g. home videos, voice mails, diary entries, and emails - where the date of production is known.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
20/WM/0116
Date of REC Opinion
15 May 2020
REC opinion
Further Information Favourable Opinion