Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech (AMYPRED)
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|ClinicalTrials.gov Identifier: NCT04828122|
Recruitment Status : Completed
First Posted : April 1, 2021
Last Update Posted : September 5, 2021
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|Condition or disease|
|Alzheimer Disease Preclinical Alzheimer's Disease Prodromal Alzheimer's Disease Alzheimer's Disease (Incl Subtypes) Mild Cognitive Impairment|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||141 participants|
|Target Follow-Up Duration:||2 Weeks|
|Official 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|
|Actual Study Start Date :||November 19, 2020|
|Actual Primary Completion Date :||August 6, 2021|
|Actual Study Completion Date :||August 6, 2021|
Arm 1: MCI amyloid positive
Arm 2: MCI amyloid negative
Arm 3: CN amyloid positive
Arm 4: CN amyloid negative
- The area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms using speech recordings as input. [ Time Frame: baseline ]
- The sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms. [ Time Frame: baseline ]
- The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive cognitively normal (CN) (Arm 3) and amyloid negative cognitively normal (CN) (Arm 4) Arms. [ Time Frame: baseline ]
- The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive MCI (Arm 1) and amyloid negative MCI (Arm 2) Arms. [ Time Frame: baseline ]
- The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between the MCI (Arms 1 and 2) and the CN (Arms 3 and 4) Arms. [ Time Frame: baseline ]
- The agreement between the PACC5 composite and the corresponding regression model predicting it in all four Arms, as measured by the coefficient of individual agreement (CIA). [ Time Frame: baseline ]
- For each classifier/regressor in outcome 1-6, the correlation between the AUC/CIA and each age group, gender and speech-to-reverberation modulation energy ratio group, as measured by the Kendall rank correlation coefficient. [ Time Frame: baseline ]
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|Ages Eligible for Study:||50 Years to 85 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828122
|Birmingham, United Kingdom, B16 8LT|
|Guildford, United Kingdom, GU2 7YD|
|London, United Kingdom, W1G 9JF|
|Plymouth, United Kingdom, PL68BT|
|Principal Investigator:||Emil Fristed, MSc||Novoic Limited|
|Responsible Party:||Novoic Limited|
|Other Study ID Numbers:||
|First Posted:||April 1, 2021 Key Record Dates|
|Last Update Posted:||September 5, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Preclinical Alzheimer's disease
Prodromal Alzheimer's disease
Mild Cognitive Impairment
Central Nervous System Diseases
Nervous System Diseases