Neurochem Inc has reported additional positive interim data on cognitive function in 18 patients with mild 1-to-moderate2 Alzheimer's Disease (AD). The results relate to patients who have completed both the three-month randomized Phase II clinical trial and an additional 13 months of treatment in the open-label Phase II extension study (OLPES) with the investigational product candidate, Alzhemed.
The data is based on cognitive function as measured by the ADAS-cog3 test.
Out of the 30 AD patients who had previously completed 12 months of treatment on Alzhemed, Neurochem is reporting on the 23 mild-to-moderate AD patients who have received the product candidate for 16 months. The mild-to-moderate AD patients (n=18)4 showed an average ADAS-cog score of +2.33 points, as opposed to +9.65 points on average in comparable historical controls5 with AD patients. The mild AD patients (n= 11) responded the best and showed a change from baseline in their average ADAS-cog score of -0.09 points. This result compares favorably with a score of +7.62 points on average in comparable historical controls. Five patients discontinued the treatment but not for reasons of drug related adverse events. The Company will report on the seven other patients later once they complete 16-months of treatment with Alzhemed.
Overall 82 per cent of the mild AD patients had stabilized or improved cognitive function tests even after 16 months of treatment with Alzhemed.
"Neurochem's product candidate, Alzhemed has the potential to modify the progression of AD by acting directly on its core pathology, something which is of critical importance in the treatment of this disease, and something we have not seen before," said Dr. Serge Gauthier, Professor of Neurology and Neurosurgery, Psychiatry, Medicine and Associate Member of Pharmacology and Therapeutics at McGill University, former President of the Consortium of Canadian Centres for Clinical Cognitive Research (C5R) and co-President of the Symposium with Drs Ezio Giacobini and Jean-Pierre Michel from Geneva.
"Alzhemed represents what we believe will become the new paradigm for AD treatment. Unlike current therapies, which treat just the symptoms of the disease, Alzhemed seems to address the underlying cause. If cleared by regulatory agencies, Alzhemed could provide an important treatment to benefit millions of Alzheimer patients," Dr. Gauthier concluded.