AFFiRis is today (Wednesday 4 June) announcing that ADO4 could be the first ever drug to demonstrate disease modifying properties in Alzheimer's patients.
The phase II clinical trial involved over 300 people with Alzheimer's disease, providing them with different doses of two compounds AD02 and AD04. Results showed that 47 per cent of the patients stabilised with regards to their cognitive / functional status. The study also showed that this effect was statistically correlated with rescue of the hippocampus, the region of the human brain where cognitive and memory functions are located. Results were more prominent in people with early onset Alzheimer's disease. This was not a controlled study, with no placebo group running alongside the groups who received the compounds.
According to AFFiRiS, these results for the first time meet all the criteria for disease modifications defined by US and European Regulatory.
Dr Doug Brown, Director of Research and Development at Alzheimer's Society said of the findings:
'Having a newly tested drug produce seemingly positive results for people with Alzheimer's disease is promising. This drug targets amyloid in the brain, which is an approach a number of other ongoing studies are also taking. We are yet to see the full set of results from this trial which will give us a better idea of the true promise of this potential treatment. That said, as a minimum we need to see more rigorous further testing of this drug in many more people with the condition to understand whether this really could slow or stop Alzheimer's in its tracks.
'There are few treatments and no cure for dementia which is why Alzheimer's Society is committed to exploring ways to develop better treatments for dementia. Our Drug Discovery programme is attempting to speed up this process by testing drugs available for other conditions that show promise for different forms of dementia.'