Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-19

Study Completion Date

2024-06-07

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

No interventions assigned to this group

Arm 2: MCI amyloid negative

* Non-AD Mild Cognitive Impairment (MCI)
* Negative amyloid PET or amyloid CSF status.
* MMSE 23-30 (inclusive)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

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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 consents to take part in FUTURE extension study.