pre-trial result keywords: significantly... significantly.... strong
The IMAGINE Trial is a randomised, double-blind and placebo-controlled study which is assessing the safety and tolerability of PBT2, and its effect on amyloid deposition in the brains of patients with prodromal or mild Alzheimer’s disease.
The trial has successfully recruited 42 patients via hospital test sites across the state of Victoria, in Australia. Patients have commenced one year (52 weeks) of treatment with either a daily placebo tablet or 250mg of PBT2.
Participants are undergoing brain scans to measure PBT2’s effect on amyloid deposits in the brain and effects on increasing brain activity. Cognition effects are being measured using a scientifically validated test that measures the type of cognitive problems experienced by prodromal and early Alzheimer’s patients.
It is thought PBT2 would benefit Alzheimer’s disease patients by selectively binding to, and redistributing, brain metals (copper, zinc) that have become imbalanced due to disease or the ageing process. This would prevent build-up of a toxic by-product of this imbalance – Abeta – which is implicated in neurodegenerative disease.
In an earlier 12-week, Phase 2a Alzheimer’s Disease trial, PBT2 significantly reduced the level of Abeta protein in the spinal fluid of treated patients and significantly improved their cognitive Executive Function.1,2,3
The trial has received funding from the Alzheimer’s Drug Discovery Foundation (ADDF), the only non-profit organization whose sole mission is to accelerate the discovery and development of drugs to prevent, treat and cure Alzheimer’s disease.
There is strong data in support of PBT2 delivering a meaningful clinical benefit to Alzheimer’s disease patients.
IMAGINE EXTENSION TRIAL
In July 2013, Prana announced that the Austin Health Human Research Ethics Committee (HREC) approved a 12-month open label extension study for patients completing the double- blind placebo-controlled IMAGINE trial. There is no placebo group in the Extension trial. All participants receive a once daily dose of 250mg of PBT2. PBT2 is Prana’s drug in Phase 2 development for Alzheimer’s and Huntington’s diseases.
The approval followed a full review by the Austin Health HREC of the potential benefit to patients and safety data collected during the IMAGINE trial.
All patients in the IMAGINE trial were given the opportunity to participate in the Extension trial. Participation in the Extension study required patients to consent to receive PBT2 for 12 months following the end of the IMAGINE trial, as well as undergoing further brain scans, blood tests and cognitive testing.
A total of 33 patients have elected to go into the Extension trial, representing 83% of the 40 patients who completed 12 months of treatment in the IMAGINE trial.