Status:
COMPLETED
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech
Lead Sponsor:
Novoic Limited
Conditions:
Alzheimer Disease
Preclinical Alzheimer's Disease
Eligibility:
All Genders
50-85 years
Brief 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 Alzhe...
Eligibility Criteria
Inclusion
- Amyloid status must be known, based on an amyloid PET scan or CSF amyloid test, no older than 30 months at the time of consent for Arm 2 and Arm 4 participants (amyloid negative Arms).
- Amyloid status must be known, based on an amyloid PET scan or CSF amyloid test, no older than 60 months at the time of consent for Arm 1 and Arm 3 (amyloid positive Arms).
- Subjects must be aged 50-85 (inclusive).
- Subjects must have MMSE scores of 23-30 (inclusive) based on a test not older than 1 month at the time of the visit.
- Date of diagnosis (if applicable) maximum of five years prior to consent.
- Subjects' first language must be English.
- Willing to participate in a study investigating speech and Alzheimer's disease.
- Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient in-person contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities. This is most likely met when living with a caregiver.
- Able to provide valid informed consent
- Able to use, or has a caregiver who is able to use a smartphone device.
- Has access to a smartphone device running an operation system of Android 7 or above; or iOS 11 or above.
- If taking part in the study through virtual visits, the following inclusion criteria also applies:
- Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
- Has access to a personal computing device of that is running an operating system of macOS X with macOS 10.9 or later, or Windows 7 or above, or Ubuntu 12.04 or higher; OR has access internet browser software Internet Explorer version 11 or above; or Microsoft Edge version 12 or above, or Firefox version 27 or above, or Google Chrome version 30 or above, or Safari version 7 or above; AND capable of audio and video recording; AND able to connect to the internet.
Exclusion
- Clinically significant unstable psychiatric illness in 6 months.
- Diagnosis of Generalised Anxiety Disorder (GAD).
- Diagnosis of Major Depressive Disorder (MDD).
- History or presence of stroke within the past 2 years.
- Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
- The participant is using drugs to treat symptoms related to AD, and the doses of these drugs were not stable for at least 8 weeks prior to consent.
Key Trial Info
Start Date :
November 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 6 2021
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04828122
Start Date
November 19 2020
End Date
August 6 2021
Last Update
September 5 2021
Active Locations (4)
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1
Re:Cognition Health
Birmingham, United Kingdom, B16 8LT
2
Re:Cognition Health
Guildford, United Kingdom, GU2 7YD
3
Re:Cognition Health
London, United Kingdom, W1G 9JF
4
Re:Cognition Health
Plymouth, United Kingdom, PL68BT