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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

56 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBT2

Drug

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

Sponsors and collaborators

Lead sponsor

Prana Biotechnology Limited

Industry

Registry information

Official study title

A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Three-Group Study to Assess the Safety, Tolerability and Efficacy of Two Dose Levels of PBT2 to Slow Progression of Disease in Patients With Early Alzheimer's Disease

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: May 9, 2007
Registry last updated: Jan 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed