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

Novoic

Status: Terminated

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04846426

NOV-0100-1

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

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

Trial design

67 participants in 4 patient groups

Arm 1: MCI amyloid positive

Description:

* 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

Description:

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

Arm 3: CN amyloid positive

Description:

* 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

Description:

* Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline * Negative amyloid PET or amyloid CSF status. * MMSE 26-30 (inclusive)