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NCT04846426: AMYPRED-FUTURE
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - FUTURE Extension
trial in Alzheimer Disease in 67 participants. Terminated before completion.
2 December 2022
Quick facts
| Lead sponsor | Novoic Limited |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 67 |
| Start date | 19 November 2020 |
| Primary completion | 2 December 2022 |
| Estimated completion | 7 June 2024 |
| Sites | 4 locations across United Kingdom |
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Preclinical Alzheimer's Disease — all drugs for Preclinical Alzheimer's Disease →
- Prodromal Alzheimer's Disease — all drugs for Prodromal Alzheimer's Disease →
- Alzheimer's Disease (Incl Subtypes) — all drugs for Alzheimer's Disease (Incl Subtypes) →
Sponsor
Novoic Limited
Who can join
Adults 50 to 85, any sex, with Alzheimer Disease or Preclinical Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in PACC5 between baseline and +12 month follow up across all four Arms, as measured by the coefficient of individual agreement (CIA) between the change in PACC5 and the corresponding regression model, trained on baseline speech data to predict it. Secondary objectives include (1) evaluating whether similar algorithms can predict change in PACC5 between baseline and +12 month follow up in the cognitively normal (CN) and MCI populations separately; (2) evaluating whether similar algorithms trained to regress against PACC5 scores at baseline, still regress significantly against PACC5 scores at +12 month follow-up, as measured by the coefficient of individual agreement (CIA) between the PACC5 composite at +12 months and the regression model, trained on baseline speech data to predict PACC5 scores at baseline; (3) evaluating whether similar algorithms can classify converters vs non-converters in the cognitively normal Arms (Arm 3 + 4), and fast vs slow decliners in the MCI Arms (Arm 1 + 2), as measured by the AUC, sensitivity, specificity and Cohen's kappa of the corresponding binary classifiers. Secondary objectives include the objectives above, but using time points of +24 months and +36 months; and finally to evaluate whether the model performance for the objectives and outcomes above improved if the model has access to speech data at 1 week, 1 month, and 3 month timepoints.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04846426
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Novoic Limited trials
Trials by the same sponsor.
- NCT05298501 — Assessing Performance on Speech Tasks Via Crowdsourced Participants · terminated
- NCT04928690 — Prediction of Amyloid and Mild Cognitive Impairment in Early Stage Alzheimer's Disease From Remote Speech Phenotyping · unknown
- NCT04939818 — Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders · completed
- NCT04937959 — Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension · unknown
- NCT04928976 — Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04846426 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novoic Limited
- Last refreshed: 14 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04846426.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing