Title: KEEPING EUROPE IN THE MAINSTREAM OF THE DEVELOPMENT OF DRUGS FOR NEURODEGENERATIVE DISEASES: The cas
1KEEPING EUROPE IN THE MAINSTREAM OF THE
DEVELOPMENT OF DRUGS FOR NEURODEGENERATIVE
DISEASESThe case for a European Alzheimers
Disease Neuroimaging Initiative
2SYNOPSIS The largest project on Alzheimers
disease currently under way worldwide is the
US-based ADNI - Alzheimer's Disease Neuroimaging
Initiative, co-funded by the NIH (40M US) and
Industry (20M US), principal investigator Mike
Weiner from the University of California at San
Francisco whose aim is to validate a set of
biological markers to track the progression of
the disease and the efficacy of disease-modifying
drugs. More info on www.adni-info.org. In
Europe, two related projects are currently under
way. The ENIR Foresight Study for the
Development of a European NeuroImage Repository
is funded by the European Commission (150K ) and
aims to design the infrastructure for centralized
image collection. The Pilot European ADNI is
funded by the US-based Alzheimer's Association
(230K ) and aims to test the feasibility of the
ADNI markers in 6 European centres. More info at
www.enir.eu and www.centroalzheimer.it/E-ADNI_proj
ect.htm. The principal investigator of both is
Giovanni B Frisoni from the Italian National
Centre for Alzheimers and Mental Disordes. The
Industry board funding the US-ADNI has expressed
interest into a public-private partnership
similar to the US-ADNI to fund an extension of
the two ongoing European projects into a full
scale European ADNI.
3SUMMARY Alzheimers pathogenesis The role of
beta amyloid The future of Alzheimers
therapyAntiamyloid drugs halting
neurodegeneration Protocols for drugs testingThe
US Alzheimers Disease Neuroimaging
Initiative The outlook for Europe Competitors,
present projects, and the future
4ALZHEIMERS PATHOGENESISNeuronal poisoning due
to Abeta
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
Robertson Mucke, Science 2006
5THE FUTURE OF ALZHEIMERS THERAPYAntiamyloid
drugs
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
Robertson Mucke, Science 2006
6THE FUTURE OF ALZHEIMERS THERAPYHalting
neurodegeneration
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
7PROTOCOLS FOR DRUG TESTINGThe Alzheimers
Disease Neuroimaging Initiativewww.adni-info.org
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
NIH funds 40M
Corporate funds 20M AstraZeneca Bristol-Myers
Squibb Eisai Global Clinical Development Elan
Corporation plc Eli Lilly and Company GlaxoSmithKl
ine Merck and Co. Novartis Pharmaceuticals
Corporation Pfizer Inc. Wyeth Research Institute
for the Study of Aging General Electric Innogeneti
cs
8PROTOCOLS FOR DRUG TESTINGADNI in the leading
media
companies are starting to talk about pitching in
together. One new consortium is the Alzheimer's
Disease Neuroimaging Initiative, which aims to
test whether magnetic resonance imaging, blood
markers, genetic profiling and neuropsychological
testing can do a better job than existing methods
of predicting the effect of drugs on early
Alzheimer's disease. The Economist SURVEY
PHARMACEUTICALS Testing times, Jun 16th 2005
9PROTOCOLS FOR DRUG TESTINGThe Alzheimers
Disease Neuroimaging Initiative
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
10THE OUTLOOK FOR EUROPECompetitors in RCTs Japan
Australia
Japanese ADNI Takeshi Iwatsubo PI 2M US / yr for
5 yrs from Jap Min Health Seeking corporate
co-funding Australian ADNI Colin Masters PI 750K
US / yr from CSIRO Seeking corporate
co-funding Single nation are more attractive to
industry than European multinational studies
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
11THE OUTLOOK FOR EUROPEENIR pilot
E-ADNIwww.centroAlzheimer.it/E-adni_project
- ENIR Foresight Study for the Development of a
European NeuroImage Repository - Specific Support Action
- Funding 150K , European Commission
- 14 centres in 9 countries
- Aim to design the infrastructure for
centralized image collection
- Pilot European ADNI
- Funding 230K , Alzheimers Association
- 8 centres in 6 countries
- Aim to demonstrate that the core ADNI
methodology can be adopted by European Alzheimer
Centers
12THE FUTUREThe aims of the large scale project
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
13THE FUTUREConsortium for a large scale project
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
14THE FUTUREPrincipal Investigators for a large
scale project
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
15THE FUTUREStakeholders of a possible large scale
project
Alzheimers pathogenesis The role of amyloid The
future of Alzheimers therapyAntiamyloid drugs
halting neurodegen. Protocols for drugs
testingThe US ADNI The outlook for
EU Competitors, present projects, the future
- Pilot E-ADNI PIs
- European Alzheimers Disease Consortium
- European Commission
- Alzheimers Association
- US-ADNI Industrial Scientific Advisory Board
16CONTACTS Giovanni B Frisoni Pilot E-ADNI and
ENIR Principal Investigator CENTRO SAN GIOVANNI
DI DIO FATEBENEFRATELLI IRCCS - Istituto di
Ricovero e Cura a Carattere Scientifico via
Pilastroni 4, 25125 Brescia, Italy gfrisoni_at_fatebe
nefratelli.it, Tel 39 030 3501261 Bruno
Vellas Principal Investigator EADC Professor of
Medicine Chief Alzheimer's Disease Research and
Clinical Center Chairman Department of Internal
Medicine and Geriatircs CENTRE HOSPITALIER
UNIVERSITAIRE PURPAN-CASSELARDIT 170 Avenue de
Casselardit, 31300 Toulouse, France vellas.b_at_chu-t
oulouse.fr, Tel 33 561 777649 Bengt
Winblad Associate Principal Investigator
EADC Professor of Geriatrics Chief Neurotec,
KAROLINSKA INSTITUTET Novum, Plan 5, KASPAC, 141
57 Huddinge, Sweden b.winblad.kaspac_at_neurotec.ki.s
e, Tel 46 70 6326771