CompletedPhase 2ACTRN12611001008910

A Phase II clinical trial to assess the safety and tolerability of PBT2 and its effect on amyloid levels in the brains of patients with prodromal or mild Alzheimer's disease.

A Randomised, Double-Blind, Placebo Controlled Study to Assess the Safety and Tolerability of PBT2, and its Effect on Amyloid Deposition in the Brains of Patients with Prodromal or Mild Alzheimer's Disease.


Sponsor

Alterity Therapeutics

Enrollment

42 participants

Start Date

Mar 2, 2012

Study Type

Interventional

Conditions

Summary

This is a Phase II clinical trial to examine the safety, tolerability and effect of 52 weeks treatment with PBT2 in patients with prodromal or mild Alzheimer's disease (AD). The primary objective is to compare the effect of PBT2 vs placebo on the amount of amyloid in patients brains after 52 weeks of treatment when measured by a particular type of brain scan, PiB-Positron Emission Tomography (PET). The effects of PBT2 on safety and tolerability, brain volume, brain metabolic activity, and cognition plus functional abilities will also be investigated.


Eligibility

Sex: Both males and femalesMin Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase II trial tests the safety and effectiveness of PBT2, an experimental drug, at reducing amyloid plaques in the brains of people aged 55 and older with prodromal or mild Alzheimer's disease. Participants must have confirmed amyloid deposits on a PiB-PET brain scan and an MMSE score of 20 or higher.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PBT2 is supplied as 250mg immediate-release capsules. The dose for this study is 250mg / day ie. one capsule is to be taken orally, once a day for 52 weeks duration.

PBT2 is supplied as 250mg immediate-release capsules. The dose for this study is 250mg / day ie. one capsule is to be taken orally, once a day for 52 weeks duration.


Locations(5)

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

VIC, Australia

Caulfield Hospital - Caulfield

VIC, Australia

Delmont Private Hospital - Glen Iris

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12611001008910