A Study to Evaluate the Ability of Speech- and Language-based Digital Biomarkers to Detect and Characterise Prodromal and Preclinical Alzheimer's Disease in a Clinical Setting - AMYPRED-US PAST Extension Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Subject hasn't completed the full visit day in the AMYPRED-US study.
结局指标
主要结局
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.
时间窗: Up to 85 years
Using archival spoken or written language samples as input.
次要结局
- The sensitivity of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms.(Up to 85 years)
- The AUC of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms.(Up to 85 years)
- The Cohen's kappa of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms using archival spoken or written language samples as input.(Up to 85 years)
- The Cohen's kappa of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms.(Up to 85 years)
- The sensitivity of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms using archival spoken or written language samples as input.(Up to 85 years)
- The specificity of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms using archival spoken or written language samples as input.(Up to 85 years)
- The AUC of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms.(Up to 85 years)
- The specificity of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms.(Up to 85 years)
- The Cohen's kappa of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms.(Up to 85 years)
- The specificity of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms.(Up to 85 years)
- The sensitivity of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms.(Up to 85 years)