δ in Dementia Clinical Trials

Title: "Novel Methods for Clinical Trials in Dementia and Cognitive Decline" Study Description: This is a double-blind assignment clinical study to test novel approaches to clinical trial methods. 1) The study team will pre-select cases most likely to benefit from adipokine modulation by a telephone assessment. 2) The study team will pre-select subjects with clinical and preclinical dementia most likely to respond to therapy. 3) The study team will test the drug donepezil's effect on dementia severity, in predicted responders and non-responders, as measured by a latent dementia phenotype "δ' and 4) test a latent Adipokines biomarker construct as a mediator of their association in the predicted responders. Objectives: Primary Objective: To assess donepezil's effect on dementia severity as measured by δ in LOI subgroups and across LOI subgroups. Secondary Objective: To test Adipokines as a mediator of donepezil's effect on dTEL. Tertiary/Exploratory: To test whether donepezil reverses dementia in cases preselected to by "LOI" analysis.