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PROSA — A Low-burden High-frequency PROgnostic Digital Speech Biomarker to Improve Future Confirmatory ALS and FTD Trials

PROSA — A Low-burden High-frequency PROgnostic Digital Speech Biomarker to Improve Future Confirmatory ALS and FTD Trials - PROSA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00031603
Enrollment
225
Registered
2023-05-10
Start date
2023-02-08
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G12.2 G31.0

Interventions

Group 1: Patients with ALS/FTD and healthy controls are called four times within one year by automated call or by a study staff member. Tasks on cognition, speech motor skills and breathing are perfor

Sponsors

DZNE Rostock/Greifswald
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participant in DESCRIBE-ALS or -FDT oder DANCER Presence of either ALS or FTD (PPA, bvFTD) (46)) Sufficient knowledge of German to understand participant information, consent form, and questionnaires. Independent ability to give consent or consenting caregiver(s) signed and dated informed consent form

Exclusion criteria

Exclusion criteria: no participant in DESCRIBE-ALS or -FDT oder DANCER Significantly impaired hearing extinguished ability to communicate

Design outcomes

Primary

MeasureTime frame
The primary objective of PROSA is to create an easy-to-perform digital speech-based assessment battery that serves as the best proxy possible for cognitive, respiratory, and motor domains and on this battery the validation of a new prognostic language biomarker for the ALS-FTD spectrum.

Secondary

MeasureTime frame
The secondary objective of the study is to investigate prognostic models based on clinical outcomes at 12-months follow up. Another outcome is to test the user acceptance of automated calls and the feasibility of speech testing by telephone.

Countries

Germany

Contacts

Public ContactMartha;Judith Kring;Baltes

DZNE Rostock/Greifswald;DZNE Bonn

martha.kring@dzne.de;Judith.Baltes@dzne.de+49 381 494 149521;

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026