Premium
P2‐008: SAUSSUREA LAPPA AND SAFFRON‐POLYPHENOLS AS SOURCE FOR ALZHEIMER'S DISEASE THERAPEUTICS
Author(s) -
Iqbal Saleem
Publication year - 2019
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2019.06.1230
Subject(s) - donepezil , acetylcholinesterase , context (archaeology) , chemistry , nucleus basalis , pharmacology , rivastigmine , aché , neuroprotection , hippocampus , cholinergic , neuroscience , biochemistry , dementia , acetylcholine , medicine , cholinergic neuron , disease , psychology , enzyme , biology , paleontology
of Vafidemstat, using multiple scales and measures across diverse AD domains, including analysis of CSF biomarkers and proteomics. It is a double-blind, multinational-multicentric, randomised, parallel-group study with a placebo-controlled 24-week Treatment Period followed by a non placebo-controlled 24week Extension Period. Doses up to 1.2 mg will be tested and 125 patients will be randomised in Spain, France and UK, besides 25 patients in US. Results: Gratifyingly, ETHERAL preliminary data show safety and no hematological dysfunction in elderly patients. Blinded safety assessments of all European-based study subjects will be presented as per June cut-off, with particular emphasis on hematology. Recruitment plans suggest that available data will include the blinded PK analysis and safety evaluation at 3 months of treatment for 70% of participants. Conclusions: In this first epigenetic Phase II in AD, ETHERAL aims to demonstrate the safety of Vafidemstat chronically administered at doses predicted to be efficacious in AD, providing initial support for the effect of its unique MoA on the clinical presentation across the AD phenotype. Interim results Q4 2019.