Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech (AMYPRED)
3. september 2021 oppdatert av: 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).
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Faktiske)
141
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Birmingham, Storbritannia, B16 8LT
- Re:Cognition Health
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Guildford, Storbritannia, GU2 7YD
- Re:Cognition Health
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London, Storbritannia, W1G 9JF
- Re:Cognition Health
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Plymouth, Storbritannia, PL68BT
- Re:Cognition Health
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Emil Fristed, MSc, Novoic Limited
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. november 2020
Primær fullføring (Faktiske)
6. august 2021
Studiet fullført (Faktiske)
6. august 2021
Datoer for studieregistrering
Først innsendt
26. mars 2021
Først innsendt som oppfylte QC-kriteriene
30. mars 2021
Først lagt ut (Faktiske)
1. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. september 2021
Sist bekreftet
1. mars 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NOV-0100
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