Study Evaluating the Safety, Tolerability and Efficacy of PBT2 in Patients With Early Alzheimer's Disease

Prana Biotechnology Limited80 enrolled

Overview

The purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of PBT2 administered for 12 weeks compared to placebo in patients with early Alzheimer's disease treated with an acetylcholinesterase inhibitor.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

PBT2DRUG

Eligibility

Sex: ALLMin age: 56 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of probable early Alzheimer's disease * stable dose of acetylcholinesterase inhibitor * community dwelling * stable medical condition Exclusion Criteria: * unstable and significant medical conditions * recurrent major psychiatric disorder * treatment with memantine

Locations (15)

Unnamed facility

Sydney, New South Wales, Australia

Unnamed facility

Sydney, New South Wales, Australia

Unnamed facility

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Safety

Time frame: Study duration

Secondary Outcomes

Change from baseline in biomarkers; Change from baseline in cognitive and global function scales

Time frame: Study duration

Data from ClinicalTrials.gov

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