View clinical trials related to Prodromal Alzheimer's Disease.
Filter by: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).
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).
The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to Alzheimer's Disease (MCI due to AD) also known as prodromal AD. Participants will be randomized to receive placebo or AGB101 (220 mg), once daily for 78 weeks. Secondary objectives are to assess the effect of AGB101 compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire (FAQ).
This study consists of Part I and an optional Part II. The purpose of Part I is to compare the plasma pharmacokinetics of verubecestat (MK-8931) following administration of a single oral dose of 40 mg MK-8931 to participants with moderate hepatic insufficiency (HI) to that of healthy matched controls. An interim safety and pharmacokinetic analysis on the basis of Part I will be performed in order to support the decision to continue with the optional Part II. If a decision to continue with Part II is made, participants with mild HI will be enrolled to receive a single oral dose of 40mg MK-8931. If any healthy participants from Part I do not meet the matching criteria for Part II additional healthy participants will be enrolled.