Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - FUTURE Extension

NCT04951284 | Terminated

• 1 other identifier: NOV-0110-1
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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 Preclinical Alzheimer's Clinical Composite with semantic processing (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 Area Under the Curve (AUC) of the receiver operating characteristic curve, 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.

Conditions

Alzheimer Disease; Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Alzheimer's Disease (Incl Subtypes); Mild Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The agreement between the change in the PACC5 composite between baseline and +12 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms, as measured by the coefficient of individual agreement (CIA).

  12 months

Secondary Outcomes (35)

• The agreement between the change in the PACC5 composite between baseline and +24 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms, as measured by the coefficient of individual agreement (CIA).

  24 months

• The agreement between the change in the PACC5 composite between baseline and +36 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms, as measured by the coefficient of individual agreement (CIA).

  36 months

• The agreement between the change in the PACC5 composite between baseline and +12 months and the corresponding regression model, trained on baseline speech data, to predict it in the CN Arms (Arms 3 and 4), as measured by the CIA.

  12 months

• The agreement between the change in the PACC5 composite between baseline and +24 months and the corresponding regression model, trained on baseline speech data, to predict it in the CN Arms (Arms 3 and 4), as measured by the CIA.

  24 months

• The agreement between the change in the PACC5 composite between baseline and +36 months and the corresponding regression model, trained on baseline speech data, predicting it in the MCI Arms (Arms 1 and 2), as measured by the CIA.

  36 months

Study Arms (4)

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 * 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)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified from participants of the AMYPRED-US study.

You may qualify if:

• Subjects are fully eligible for and have completed the AMYPRED-US (Amyloid Prediction in early stage Alzheimer's disease from acoustic and linguistic patterns of speech) study.
• (See https://clinicaltrials.gov/ct2/show/NCT04928976)
• \- Subject consents to take part in FUTURE extension study.

You may not qualify if:

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

Sponsors & Collaborators

• Novoic Limited: lead

Study Sites (1)

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Speech; Language

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Verbal Behavior; Communication; Behavior

Study Officials

• Emil Fristed, MSc

  Novoic Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 6, 2021
• Study Start: January 21, 2021
• Primary Completion: November 21, 2022
• Study Completion: May 28, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (1)