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FDA, Leading Stakeholders in CNS Drug Development Address Concerns Regarding Amyloid Hypothesis in Alzheimer's Disease

At the 7^th Annual Meeting of the Society, a diverse partnership of drug developers, academic researchers, and policy makers gathered to consider several critical topics, including the difficulties being experienced in developing treatments targeting the cause of Alzheimer's Disease.

The Society devoted a session to discuss the lack of therapeutic progress debating "Do Clinical Results to Date Suggest that Drug Development Based on the Amyloid Hypothesis of Alzheimer's Disease Is Dead?" This session brought together academic, pharmaceutical , and regulatory perspectives to discuss why and how to develop next-phase approaches for dementia treatment trials.

While there was consensus that the amyloid cascade hypothesis adequately explains the mis-metabolism of amyloid in Alzheimer's Disease, there was concern that both pre-clinical experiments and therapeutic efforts have not borne fruit. Experiments using genetically modified animals do not capture either the common morphological or clinical features of Alzheimer's Disease. Treatments based on the amyloid hypothesis have not demonstrated any therapeutic benefit, but in some trials, have shown some capacity to adversely affect patients. Regulatory feedback has indicated that evidence of clinical benefit, or at least a significant effect on a validated surrogate measure would be needed to approve a treatment that would modify disease progression.

There was consensus, that there is a need to significantly expand basic research to target other than amyloid, address basic issues relating to amyloid hypothesis, share clinical data from multiple sources including international research, and consider how to design, conduct, and fund long-term trials performed in at-risk and early stage patients.

There is growing concern at the lack of therapeutic progress based on current hypotheses. The field needs to re-evaluate its current efforts and prioritize research to enable the development of treatments that would ameliorate the plight of millions of AD patients and their caregivers worldwide.

Other topics covered at this year's meeting include:

• In this year's Mental Health Research-to-Policy Forum: the Impact of National Health Reform and Shifting National Priorities on Mental Health Research-to-Policy-to-Implementation.
• Class Labeling: Implications for Treatment and Challenges to Differentiation in Development.
• Facing the Challenges of Biomarkers (Wednesday 23 February)

The 7th Annual Scientific Meeting is being held at The Fairmont Washington DC from Monday 21 February through Wednesday 23 February, 2011.

About ISCTM: The ISCTM gathers representatives from clinical and academic specialties, the pharmaceutical industry, and regulatory bodies to evaluate critical clinical and public-health challenges twice annually. It examines the development of novel treatments for major psychiatric and neuropsychiatric disorders and works to support advances in methods for evaluating treatments that are scientifically sound, ethical, and feasible.

ISCTM
Carlotta McKee, Executive Director, 615-383-7688
isctm@isctm.org