Study: NCT04311515

Intervention type: RADIATION
Group type: PLACEBO_COMPARATOR
Intervention: Tau Positron emission tomography (PET)
Description: Tau PET imaging enables the longitudinal assessment of the spatial pattern of tau deposition. Tau accumulates with progression of AD dementia and may be sensitive to disease related changes, particularly those due to intervention with a drug thought to work through a tau related mechanism. Quantitative assessments will be utilized to evaluate the target engagement and pharmacological effects of PU-AD after 6 months of treatment

Intervention type: RADIATION
Group type: ACTIVE_COMPARATOR
Intervention: Fluorodeoxyglucose (FDG) Positron emission tomography (PET)
Description: Measurement of neuronal function with FDG PET can help to understand the relationship between target engagement and potential clinical effects. FDG PET will be acquired using stringent quality control. Since glucose metabolism captures all neuronal activity, in order to isolate effects due to treatment, patients will be maintained in a consistent state during the tracer uptake period. Subject motion during image acquisition will be minimized and monitored. Images will be quality controlled, processed, and measured quantitatively using methods that maximize signal to noise associated with technical and physiologic variability

Intervention type: RADIATION
Group type: PLACEBO_COMPARATOR
Intervention: Fluorodeoxyglucose (FDG) Positron emission tomography (PET)
Description: Measurement of neuronal function with FDG PET can help to understand the relationship between target engagement and potential clinical effects. FDG PET will be acquired using stringent quality control. Since glucose metabolism captures all neuronal activity, in order to isolate effects due to treatment, patients will be maintained in a consistent state during the tracer uptake period. Subject motion during image acquisition will be minimized and monitored. Images will be quality controlled, processed, and measured quantitatively using methods that maximize signal to noise associated with technical and physiologic variability

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Cerebrospinal fluid (CSF) Biomarkers
Description: A broad set of biomarkers are being assessed in this study to indicate whether this treatment is able to impact multiple pathways associated with AD related to neurodegeneration

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Cerebrospinal fluid (CSF) Biomarkers
Description: A broad set of biomarkers are being assessed in this study to indicate whether this treatment is able to impact multiple pathways associated with AD related to neurodegeneration

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Blood Biomarkers
Description: Changes in blood biomarkers may be observable if treatment affects cerebral amyloidosis and loss of nerve cells

Intervention type: DIAGNOSTIC_TEST
Group type: PLACEBO_COMPARATOR
Intervention: Blood Biomarkers
Description: Changes in blood biomarkers may be observable if treatment affects cerebral amyloidosis and loss of nerve cells