Clinical trial of Alzheimer's disease drug shows clear reductions in AD development
16 December 2003
A new clinical trial has shown that a treatment for Alzheimer's disease slowed the progression of cognitive decline in a group of patients with moderate to severe symptoms.
The study enrolled 36 patients who were assessed for indicators of cognitive performance such as memory, orientation, language, attention and reasoning. The results were assessed using a cognitive score on the Alzheimer's disease Assessment Scale, the so-called ADAS-cog score. The scores range from 0 to 70, with lower scores indicating a healthy adult. As dementia progresses, the score increases. Eighteen of the patients were assigned to placebo and 18 received Prana's Alzheimer's disease drug, PBT-1 (Clioquinol) (the first of Prana's metal protein attenuating compounds (MPACs) to be developed for Alzheimer's disease). PBT-1 is a chemical that binds zinc and copper, and has been shown to lower the levels of Ab and the associated toxicity in the brains of Transgenic mice used as a model of Alzheimer's Disease.
The more affected patients entering Prana's pilot clinical trial (i.e. those with higher ADAS-cog scores) showed an average change in score at 24 weeks of about 1.5 points on PBT-1 and about 8.9 on placebo, a difference of 7.4. Generally, untreated patients with mild to moderate disease could be expected to gain six to 12 points in their ADAS-cog score over 12 months. A panel convened by the Food and Drug Administration in the US deemed an improvement of four points would be clinically significant.
"The results of this trial have been very encouraging to a clinician," said Dr Craig Ritchie of UCL, who led the study. "Our findings have led to the development by Prana Biotechnology of new, possibly more effective drugs which hit the same target as Clioquinol. UCL plans to be involved in further testing of the principal using Clioquinol in a larger, UK multi-centre study which is seeking public funding."
Dr Susanne Sorensen, Head of Research at the Alzheimer's Society says: "The
Alzheimer's Society welcomes this research as the results indicate that there
may be a novel use for this already existing drug in the treatment of Alzheimer's
disease. The trial presented here is limited in its scale and the Alzheimer's
Society believes it would be valuable to see a larger scale trial. The potential
for new drugs that may interfere with or revert the progression of Alzheimer's
disease gives hope to people with dementia and their carers. There are currently
only limited and expensive treatment options available for Alzheimer's disease
and none that revert the disease for more than a short period."
Notes to editors:
- "Metal-Protein Attenuation with Iodochlorhydroxyquin (Clioquinol) Targeting A ß Amyloid Deposition and Toxicity in Alzheimer Disease" is published on Monday 15th December in the Archives of Neurology.
- To speak to Dr Ritchie or arrange an interview, please contact the UCL media relations team.
- Prana - Based in Australia, incorporated in 1997 and listed on the Australian Stock Exchange in March 2000, Prana Biotechnology (Nasdaq: PRAN; ASX: PBT) was established to commercialise research into Alzheimer's disease and other major age-related degenerative disorders. Its mission is to develop diagnostic and therapeutic drugs to treat the central disease pathways that cause degeneration of the brain as the aging process progresses. Prana's technology has emerged from its researchers at prominent international institutions such as Massachusetts General Hospital at Harvard Medical School and the University of Melbourne. For further information, please visit the web site at www.pranabio.com