A Phase II Extension study 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.

An Open Label Extension 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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000777796

Acronym

PBT2-204-Ext

Enrollment

Registered

2013-07-11

Start date

2013-07-24

Completion date

2013-12-03

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a Phase II Extension study 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 objectives are to examine the safety and tolerability and the effect of PBT2 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 brain volume, brain metabolic activity, blood biomarkers of AD and cognition plus functional abilities will also be investigated.

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. Information on compliance will be collected via a Diary Card and accountability of drug returns. It is also the role of the Study Partner to over-see the daily taking of study drug.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

55 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients who have completed Visit 10 (Week 52) of the PBT2-204 (IMAGINE) clinical trial [ACTRN12611001008910].

Exclusion criteria

1. Allergy to PBT2 or its excipients (microcrystalline cellulose, pregelatinised starch, colloidal silicon dioxide, povidone K29/32 and sodium stearyl fumurate). 2. Have developed any clinically significant uncontrolled medical, ocular or psychiatric illness during PBT2-204.

Outcome results