An observational study in Alzheimer Disease, Preclinical Alzheimer's Disease and Prodromal Alzheimer's Disease, sponsored by Novoic Limited. Completed at 4 sites in United Kingdom. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Novoic Limited · Observational
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, as measured by the 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. Secondary objectives include (1) evaluating whether similar algorithms can detect amyloid-specific cognitive impairment in the cognitively normal (CN) and MCI Arms respectively, as measured on binary classifier performance; (2) whether they can detect MCI, as measured on binary classifier performance (AUC, sensitivity, specificity, Cohen's kappa), and the agreement between the PACC5 composite and the corresponding regression model predicting it in all Arms pooled (Wilcoxon signed-rank test, CIA); (3) evaluating variables that can impact performance of such algorithms of covariates from the speaker (age, gender, education level) and environment (measures of acoustic quality).
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 141 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Novoic Limited is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All participants of the study are based in the UK.
If taking part in the study through virtual visits, the following inclusion criteria also applies:
Exclusion Criteria:
1. 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 2. Positive amyloid PET or amyloid CSF status. 3. MMSE 23-30 (inclusive)
1. Non-AD Mild Cognitive Impairment (MCI) 2. Negative amyloid PET or amyloid CSF status. 3. MMSE 23-30 (inclusive)
1. Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline 2. Positive amyloid PET or amyloid CSF status. 3. MMSE 26-30 (inclusive)
1. Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline 2. Negative amyloid PET or amyloid CSF status. 3. MMSE 26-30 (inclusive)
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 using speech recordings as input.
Time frame: baseline
The sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms.
Time frame: baseline
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive cognitively normal (CN) (Arm 3) and amyloid negative cognitively normal (CN) (Arm 4) Arms.
Time frame: baseline
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive MCI (Arm 1) and amyloid negative MCI (Arm 2) Arms.
Time frame: baseline
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between the MCI (Arms 1 and 2) and the CN (Arms 3 and 4) Arms.
Time frame: baseline
The agreement between the PACC5 composite and the corresponding regression model predicting it in all four Arms, as measured by the coefficient of individual agreement (CIA).
Time frame: baseline
For each classifier/regressor in outcome 1-6, the correlation between the AUC/CIA and each age group, gender and speech-to-reverberation modulation energy ratio group, as measured by the Kendall rank correlation coefficient.
Time frame: baseline
Plan to share: Undecided
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Novoic Limited