Prana Biotechnology has completed recruiting patients with Alzheimer's disease in a Phase II trial testing the drug PBT2.
IMAGINE, a double-blind placebo-controlled 12 month study, has enrolled 41 patients with prodromal or mild Alzheimer's Disease in Melbourne, Australia, with an additional patient expected, pending final screening procedures.
Prana executive chairman Geoffrey Kempler said; "We expect that the current 12 month IMAGINE trial will provide further evidence of PBT2's ability to have a positive effect in the brain and help Alzheimer's patients."
Trial participants are undergoing brain scans using PiB-PET scanning to measure PBT2's effect on amyloid deposits in the brain and increased brain activity.
The Neuropsychological Test Battery (NTB), a test that measures the type of cognitive problems experienced by prodromal and early Alzheimer's patients, is being used to measure cognition effects in the participants.
Alzheimer's Drug Discovery Foundation executive director Dr Howard Fillit said; "Success in this trial will demonstrate target engagement by PBT2 in the brains of people with Alzheimer's Disease, and accelerate the clinical development of PBT2 to patients."
A prior 12 week Alzheimer's disease trial observed considerable Abeta protein level reduction by PBT2 in the spinal fluid of treated patients, in addition to significant improvement in their cognitive executive function.
PBT2 selectively binds and redistributes brain metals such as copper and zinc, which have become imbalanced due to disease or the ageing process.
The drug can prevent Abeta protein-induced toxicity and promote its disaggregation in the brain, according to the company.