Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech (AMYPRED)
3. september 2021 opdateret af: Novoic Limited
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
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 Alzheimer's disease, as measured by the 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.
Secondary objectives include (1) evaluating whether similar algorithms can detect amyloid-specific cognitive impairment in the cognitively normal (CN) and MCI Arms respectively, as measured on binary classifier performance; (2) whether they can detect MCI, as measured on binary classifier performance (AUC, sensitivity, specificity, Cohen's kappa), and the agreement between the PACC5 composite and the corresponding regression model predicting it in all Arms pooled (Wilcoxon signed-rank test, CIA); (3) evaluating variables that can impact performance of such algorithms of covariates from the speaker (age, gender, education level) and environment (measures of acoustic quality).
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
141
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Birmingham, Det Forenede Kongerige, B16 8LT
- Re:Cognition Health
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Guildford, Det Forenede Kongerige, GU2 7YD
- Re:Cognition Health
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London, Det Forenede Kongerige, W1G 9JF
- Re:Cognition Health
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Plymouth, Det Forenede Kongerige, PL68BT
- Re:Cognition Health
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All participants of the study are based in the UK.
Beskrivelse
Inclusion Criteria:
- 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 Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Arm 1: MCI amyloid positive
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Arm 2: MCI amyloid negative
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Arm 3: CN amyloid positive
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Arm 4: CN amyloid negative
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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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.
Tidsramme: baseline
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baseline
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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).
Tidsramme: baseline
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baseline
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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.
Tidsramme: baseline
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baseline
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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.
Tidsramme: baseline
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baseline
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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.
Tidsramme: baseline
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baseline
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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.
Tidsramme: baseline
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baseline
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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.
Tidsramme: baseline
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baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Emil Fristed, MSc, Novoic Limited
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. november 2020
Primær færdiggørelse (Faktiske)
6. august 2021
Studieafslutning (Faktiske)
6. august 2021
Datoer for studieregistrering
Først indsendt
26. marts 2021
Først indsendt, der opfyldte QC-kriterier
30. marts 2021
Først opslået (Faktiske)
1. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. september 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NOV-0100
Plan for individuelle deltagerdata (IPD)
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