Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension (PAST-US)

Novoic

Status: Unknown

Conditions: Normal Cognition; 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

NCT04937959

NOV-0110-2

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 detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, based on archival spoken or written language samples, as measured by the area under the curve (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 Mild Cognitive Impairment (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.

Enrollment: 40 estimated 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-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 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-US study.

Trial design

40 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 * 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)