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Non-amyloid therapies emerging for Alzheimer's at AAIC

AAIC meeting hears new clinical data from Lundbeck, Baxter, Chiesi and Takeda

Alzheimer dementia pre-senile onset 

 Histopathogic image of senile plaques in the cerebral cortex in a patient with pre-senile onset Alzheimer's disease

Scientists and clinicians met at the Alzheimer's Association International Conference (AAIC) in Boston this week to discuss the latest developments in the management of the disease. Here is a round-up of some of the key developments among non-amyloid based therapies.

Lundbeck and partner Otsuka presented data from a 278-patient phase II trial which showed their selective 5-HT6 receptor antagonist Lu AE58054 achieved an improvement in cognitive symptoms when added to primary treatment with the widely-used cholinesterase inhibitor donepezil over a six-month period. The two companies say they intend to start a three-year phase III trial of the approach in about 3,000 patients before the end of the year. They emphasise the drug represents "a different approach from the amyloid and tau hypotheses that have underpinned much of the research to date on Alzheimer's disease".

Baxter International presented additional data from its phase III GAP trial of immunoglobulin therapy Gammagard in Alzheimer's, which failed to meet its primary endpoints earlier this year. The firm provided additional data on a subgroup of patients with moderate disease, who were carriers of a genetic marker called ApoE4, indicating they appeared to gain a significant cognitive benefit from baseline compared to the placebo group. The company stopped short of saying it would consider additional testing of the drug, but indicated it would be "collaborating with scientific experts in the field of Alzheimer's research to further explore these findings".

A novel approach to treatment based on reducing inflammation in the brain using drugs called microglial modulators was presented by Chiesi Pharmaceuticals of Italy in a 70-patient study. Chiesi's CHF5074 has previously been shown to prevent brain plaque deposition and reduce deficits in transgenic mouse models of Alzheimer's, and at AAIC the first clinical results suggested it can also have a dose-dependent impact on cognitive function in patients carrying one or two copies of the ApoE4 gene.

Takeda and Zinfandel Pharmaceuticals highlighted a new approach to identifying individuals who are at risk of developing Alzheimer's dementia which could be used to support clinical trials of early treatments. The genetics-based biomarker risk algorithm - which assesses ApoE status as well as another marker called TOMM40 - has been found to show positive predictive and negative predictive values in the range of 70-80 per cent, which compare favourably with imaging and cerebrospinal fluid-based biomarkers, according to the two companies. A phase III trial is planned to further test the validity of the approach and see whether treatment with diabetes drug pioglitazone can delay the onset of dementia symptoms.

18th July 2013

From: Research



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