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Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - PAST Extension (AMYPRED-PAST)

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ClinicalTrials.gov Identifier: NCT04851496
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Novoic Limited

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 Alzheimer's disease, based on archival spoken or written language samples, as measured by the AUC of the receiver operating characteristic curve of the binary classifier distinguishing between amyloid positive and amyloid negative arms. Secondary objectives include (1) evaluating how many years before diagnosis of MCI such algorithms work, as measured on binary classifier performance of the classifiers trained to classify MCI vs cognitively normal (CN) arms using archival material from the following time bins before MCI diagnosis: 0-5 years, 5-10 years, 10-15 years, 15-20 years, 20-25 years; (2) evaluating at what age such algorithms can detect later amyloid positivity, as measured on binary classifier performance of the classifiers trained to classify amyloid positive vs amyloid negative arms using archival material from the following age bins: younger than 50, 50-55, 55-60, 65-70, 70-75 years old.

Condition or disease
Alzheimer Disease Preclinical Alzheimer's Disease Prodromal Alzheimer's Disease Alzheimer's Disease (Incl Subtypes) Mild Cognitive Impairment

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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 - PAST Extension Study.
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021


Group/Cohort
Arm 1: MCI amyloid positive
  • Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria (2011) for MCI due to Alzheimer's or Mild Alzheimer's Dementia
  • Positive amyloid PET or amyloid CSF status.
  • MMSE 23-30 (inclusive)
Arm 2: MCI amyloid negative
  • Non-AD Mild Cognitive Impairment (MCI)
  • Negative amyloid PET or amyloid CSF status.
  • MMSE 23-30 (inclusive)
Arm 3: CN amyloid positive
  • Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline
  • Positive amyloid PET or amyloid CSF status.
  • MMSE 26-30 (inclusive)
Arm 4: CN amyloid negative
  • Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline
  • Negative amyloid PET or amyloid CSF status.
  • MMSE 26-30 (inclusive)



Primary Outcome Measures :
  1. The primary outcome measure is 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. [ Time Frame: Up to 85 years ]
    Using archival spoken or written language samples as input.


Secondary Outcome Measures :
  1. 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 using archival spoken or written language samples as input. [ Time Frame: Up to 85 years ]
  2. The AUC, sensitivity, specificity and Cohen's kappa of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms. [ Time Frame: Up to 85 years ]
    Using archival spoken or written language samples as input in the following bins: 0-5 years, 5-10 years, 10-15 years, 15-20 years, 20-25 years before MCI diagnosis.

  3. The AUC, 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: Up to 85 years ]
    Using archival spoken or written language samples as input in the following bins: younger than 50, 50-55, 55-60, 65-70, 70-75 years old.



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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
Study Population
Participants will be identified from participants of the AMYPRED study.
Criteria

Inclusion Criteria:

  • Subjects are fully eligible for and have completed the AMYPRED (Amyloid Prediction in early stage Alzheimer's disease from acoustic and linguistic patterns of speech) study.

(See https://clinicaltrials.gov/ct2/show/NCT04828122)

  • Subject has access to audio or written recordings created by them that are available for collection.
  • Subject consents to take part in PAST extension study.

Exclusion Criteria:

  • Subject hasn't completed the full visit day in the AMYPRED study.

Information from the National Library of Medicine

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): NCT04851496


Contacts
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Contact: Head of Clinical Operations +447849522891 amypred@novoic.com

Locations
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United Kingdom
Re:Cognition Health Recruiting
Birmingham, United Kingdom, B16 8LT
Contact: Clinical Trials Centre Manager         
Re:Cognition Health Recruiting
Guildford, United Kingdom, GU2 7YD
Contact: Clinical Trials Centre Manager         
Re:Cognition Health Recruiting
London, United Kingdom, W1G9JF
Contact: Clinical Trials Centre Manager         
Re:Cognition Health Recruiting
Plymouth, United Kingdom, PL68BT
Contact: Clinical Trials Centre Manager         
Sponsors and Collaborators
Novoic Limited
Investigators
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Principal Investigator: Emil Fristed, MSc Novoic Limited
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Responsible Party: Novoic Limited
ClinicalTrials.gov Identifier: NCT04851496    
Other Study ID Numbers: NOV-0100-2
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novoic Limited:
Alzheimer's disease
Preclinical Alzheimer's disease
Prodromal Alzheimer's disease
Mild Cognitive Impairment
Normal Cognition
Amyloid
Speech
Acoustic
Language
Linguistic
Machine Learning
Artificial Intelligence
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders