European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer's disease

• Date:
  Monday, 24 November 2014
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

The Agency is organising this workshop following the public-consultation exercise on its concept paper on the need for revision of the guideline on medicinal products for the treatment of Alzheimer's disease and other dementias. The aim of the workshop is to make sure that, while revising its guideline, the EMA can take the most up-to-date scientific developments in understanding and treating Alzheimer's disease into consideration, as well as the positions of experts in the field. Registration is open until 01/07/2014. Places limited.

Documents

Programme of European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease

Reference Number: EMA/180375/2014

Discussion paper on the clinical investigation of medicines for the treatment of Alzheimer's disease and other dementias

Reference Number: EMA/CHMP/539931/2014 Corr.

Presentation - Subjective cognitive decline as the first symptom of Alzheimer’s disease (Frank Jessen)

Presentation - The latest advances in the understanding of the pathophysiology of Alzheimer’s disease and the development of disease-modifying therapies (Gary Romano)

Summary:

European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease

Presentation - Changing diagnostic criteria for Alzheimer’s disease - impact on clinical trials (Bruno Dubois)

Presentation - The changing diagnostic criteria for Alzheimer's disease - regulatory challenges (Marion Haberkamp)

Presentation - Developing drugs for the treatment of Alzheimer’s disease (Eric Bastings, Billy Dunn)

Presentation - Novel regulatory sience research on drugs for Alzheimer's disease - a guideline on the clinical evaluation of drugs for Alzheimer’s disease (Interim report) (Takashi Moritoyo)

Presentation - The scientific and regulatory approaches to facilitating disease-modifying drug development and registration in a global environment (Thomas Blaettler)

Summary:

European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease

Presentation - Global dementia integrated development (Raj Long)

Presentation - An approach to outcome measure development - a regulatory perspective (Elektra Papadopoulos)

Presentation - The choice of outcome parameters and need for distinct assessment tools with regard to the different disease stages in Alzheimer’s disease (Iva Holmerovà¡)

Summary:

European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease

Presentation - Accelerating drug development for Alzheimer’s disease through regulatory science (Martha Brumfield)

Presentation - Clinical outcome measures - an industry perspective (Veronika Logovinsky)

Presentation - The choice of outcome parameters and need for distinct assessment tools with regard to the different disease stages in Alzheimer's disease - regulator’s perspective (Jens Heisterberg)

Presentation - Potential use of biomarkers and their temporal relationship with the different phases of Alzheimer's disease in different stages of drug development (Olivier Blin)

Presentation - The potential use of biomarkers in Alzheimer’s disease in different stages of drug development (Johan Luthman)

Presentation - European Union regulatory perspective on the potential use of biomarkers in Alzheimer's disease drug development (Valentina Mantua)

Presentation - Drug development for behavioral and psychological symptoms of dementia in Japan (Akifumi Kamata)

Presentation - The place for treatments of associated neuropsychiatric and other symptoms in Alzheimer's disease and other dementias - patient and carers' perspective (Mary-Frances Morris)

Presentation - The place for treatments of associated neuropsychiatric and other symptoms - focus on challenges of the clinical diagnosis of Alzheimer's disease (Reinhold Schmidt)

Presentation - The place for treatments and trial design considerations for associated neuropsychiatric symptoms in Alzheimer's disease (Rachel Schindler)

Summary:

European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease

Presentation - The place for treatments of associated neuropsychiatric and other symptoms (Luca Pani)

Presentation - The changing diagnostic criteria for Alzheimer's disease, including early and asymptomatic disease stages and their impact on clinical trial design (Eric Siemers)

Presentation - Disease modifying drug development - statistical design and analysis (David Brown)

Summary:

European Medicines Agency workshop on the clinical investigation of medicines for the treatment of Alzheimer’s disease

Multimedia