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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001008910

Acronym

PBT2-204 / IMAGINE

Enrollment

Registered

2011-09-20

Start date

2012-03-02

Completion date

2012-11-28

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 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

55 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Prodromal Alzheimer's disease or mild Alzheimer's disease 2. 11C-PiB-PET positive (SUVR>1.7) 3. MMSE >or= 20

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 other primary neurodegenerative disorders associated with dementia (e.g. Parkinson’s Disease Dementia, Fronto-temporal Lobe Dementia, Lewy Body Dementia or Vascular Dementia)

Outcome results