To Evaluate Safety, Tolerability and Pharmacological Effects of PU AD in Subjects With Mild AD Dementia

Summary

The study is designed as a classic, randomized, double blind, placebo controlled, parallel group study including one active dose of PU AD and matching placebo, designed to assess safety, tolerability and pharmacological effects of oral PU AD (dihydrochloride salt) in subjects with mild AD

Conditions

• Alzheimer Disease

Interventions

RADIATION

Tau Positron emission tomography (PET)

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

RADIATION

Fluorodeoxyglucose (FDG) Positron emission tomography (PET)

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

DIAGNOSTIC_TEST

Cerebrospinal fluid (CSF) Biomarkers

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

DIAGNOSTIC_TEST

Blood Biomarkers

Changes in blood biomarkers may be observable if treatment affects cerebral amyloidosis and loss of nerve cells

BEHAVIORAL

Rating Scales

Alzheimer's Disease composite score (ADCOMS+), CDR sb, Alzheimer's Disease Assessment Scale Cognitive (ADAS cog), Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS ADL), Mini Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale Cognitive (ADAS-COG 12)

DRUG

PU-AD

PU-AD 30mg daily for 6mos

DRUG

Placebo

Placebo 30mg daily for 6mos

Sponsors & Collaborators

• Samus Therapeutics, Inc.

  lead INDUSTRY

Principal Investigators

• Michael H Silverman, MD · Samus Therapeutics Consultant

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-30

Primary Completion

2020-09-09

Completion

2022-11-15

FDA Drug

Yes

Countries

• United States

Study Locations