Biotech Daily Special Report December 20, 2006
December 20th 2006 07:46
Prana Starts
Phase IIa
Alzheimer’s Trial
Phase IIa
Alzheimer’s Trial
Prana says dosing has begun in its phase IIa clinical trial of PBT2 in patients with early Alzheimer’s disease.
The PBT2-201-Euro trial is being conducted in seven centres in Sweden and will focus on exploring the safety and tolerability of Prana’s proprietary lead compound PBT2 and its effects on the mechanism and progression of the disease, investigating both central and peripheral biomarkers of Alzheimer’s disease as well as cognition.
The principal investigator for the trial is Uppsala University department of Public Health and Geriatrics Prof Lars Lannfelt.
Prana said Prof Lannfelt and his laboratory had identified two important human mutations of Alzheimer’s disease (the Swedish and Arctic mutations) that affect the level of amyloid peptide in the brain, a key discovery in the Alzheimer’s field.
Prof Lannfelt said Sweden had been at the forefront of biomarker research for many years.
“We now understand that measurement of central biomarkers provides an important understanding of the progression of Alzheimer’s disease,” Prof Lannfelt said. “Our expertise in the collection, analysis and understanding of biomarkers has meant that many leading Alzheimer’s disease drug development companies, such as Prana, locate their important clinical biomarker studies here. If the drug can be shown to move any of these biomarkers, this will be demonstration of its potential as a mechanistic treatment for Alzheimer's disease,” Prof Lannfelt said.
The PBT2-201-Euro trial is a randomized, double blind, placebo-controlled phase IIa study, in which 80 Alzheimer's disease patients – male and female subjects 55 years or older – will randomly receive three months treatment with one of two oral dose levels of PBT2, or placebo.
Twenty patients will receive a 50mg dose, 30 patients will receive a 250mg dose, and 30 patients will receive the placebo.
The primary endpoint of the study will be the safety and tolerability of PBT2. The efficacy endpoints will be PBT2’s effect on cerebrospinal fluid and plasma biomarkers as well as cognition.
Results are expected to be announced in late 2007.
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