Recruiting

Observational Study

Sponsor:

Novoic Limited

Code:

NCT04937959

Conditions

Alzheimer Disease

Alzheimer's Disease (Incl Subtypes)

Preclinical Alzheimer's Disease

Prodromal Alzheimer's Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Study Details

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 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.

Conditions

Alzheimer Disease

Alzheimer's Disease (Incl Subtypes)

Preclinical Alzheimer's Disease

Prodromal Alzheimer's Disease

Mild Cognitive Impairment

Study ID

NCT04937959

Start date

Jan 22, 2021

Status verified date

Jun, 2021

Completion date

Aug 30, 2022

Anticipated

Primary completion date

Aug 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Head of Clinical Operations

07849522891s2@novoic.com

Locations

Syrentis Clinical Research

Recruiting

Santa Ana, California, United States, 92705

Contacts

Director of Clinical Operations

714-542-3008info@syrentis.com

More Information

Sponsor

Novoic Limited

Last update posted

Apr 7, 2022

Last verified

Jun, 2021

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novoic Limited on 2022-04-07.