Methodological study for the development of a software application for speech analysis in patients with Alzheimer’s disease ranging from mild cognitive impairment to moderate severity

• Conditions: F00.9; Dementia in Alzheimer disease, unspecified

• Registration Number: DRKS00018112
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-24
• Study Completion: 2021-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

Diagnosis of Alzheimer’s disease ranging from mild cognitive impairment to moderate severity according to NIA/AA criteria (patients) or cognitive test performance in CERAD battery within normal limits (cognitively healthy controls of comparable age)
2. Age >55 years
3. Adequate vision, hearing, comprehension of German language and speech formation abilities to allow testing

Exclusion Criteria

1. Exclusion of any other medical condition interfering with cognitive functioning, including clinical sings of depression
2. Exclusion of any medical condition which prohibits the use of a tablet-based application
3. Exclusion of any psychotropic medication that interferes with cognitive functioning/performance

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Identification of several properties of spoken speech from a German cohort of patients with Alzheimer’s disease ranging from mild cognitive impairment to moderate severity using automated speech analysis, which allow discrimination from cognitively healthy controls of comparable age<br>2. Assessment of ROC characteristics of the discriminative algorithm between patients and controls.<br><br>All assessments are taken at one time point.

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of the neuropsychological test performance features of the presented speech material for potential inclusion into a software package together with the discriminative algorithm<br>2. Building a digital infrastructure for the automated assessment of speech and memory for the early detection Alzheimer’s disease that follows legal and regulatory guidance<br>3. Adaptation of user interface or software in case of bug detection prohibiting speech sample collection collection and/or remote storage