New Study Shows Evidence of Lower Rate of Hippocampal Shrinkage in Alzheimer?s Disease Patients Treated With Aricept(R)

London (ots/PRNewswire) -

Eisai Europe Ltd and Pfizer Limited today announced the results
from a new study conducted in France demonstrating Aricept(R)
(donepezil hydrochloride) 10mg significantly reduced the rate of
hippocampal atrophy (reduction in volume) in patients with an
amnestic syndrome at an early phase of Alzheimer's disease.

The multi-centre, double-blind, randomised, placebo-controlled
study was conducted to assess the effect of donepezil on the rate of
hippocampal atrophy over one year in patients presenting an amnestic
syndrome at a mild cognitive impairment (MCI) stage of the disease. A
total of 216 patients were randomised to receive donepezil 10 mg
daily or placebo.[1] The study was conducted outside the licensed
indication for donepezil in the European Union. Aricept is licensed
for the symptomatic treatment of mild to moderately severe
Alzheimer's dementia in Europe.

The adverse events reported were consistent with the known safety
profile of donepezil.[2] The most commonly reported adverse events in
this study were headaches, nightmares, cramps, nausea and diarrhea.

Patients in the donepezil group exhibited a 45% lower rate of
hippocampal atrophy than those in the placebo group after 1 year
(-1.89% [SE=0.34] vs -3.74% [SE=0.32], p<0.001). There was no
difference between the donepezil and placebo groups on any of the
cognitive measures included in the study*. The full results of the
study will be presented at the Alzheimer's Association International
Conference 2011 (AAIC 2011) in Paris, France.

The hippocampus plays an important role in short-term and
long-term memory and spatial navigation.[3] In Alzheimer's disease,
the hippocampus is one of the first regions of the brain to suffer
damage, with symptoms often presenting as memory problems and
disorientation. Hippocampal atrophy has been identified as a common
feature in Alzheimer's disease, and shrinkage in the hippocampal
region has been shown to correlate with severity of the patient's
decline.[4]

Commenting on this new study, Professor Bruno Dubois from the
Neurological Institute of the Salpétrière University Hospital in
Paris who led the study said: "These findings are important as the
results show that subjects on donepezil 10mg displayed significantly
less hippocampal atrophy after one year compared to subjects
receiving placebo. This study also used the new diagnostic framework
recently proposed by the International Working Group for New Research
and Criteria for Diagnosis of Alzheimer's disease.[5]"

The hippocampus study is a result of a collaboration between the
top centres in France, including Hôpital de la Pitié Salpêtriere.

Notes to Editors

*Cognitive measures for the study included:

- Mean change in the sum of items of the Alzheimer's Disease
Assessment Scale - Cognitive - Mild Cognitive Impairment version
(ADAS-Cog-MCI) from Baseline to 12 month visit
- Mean change from Baseline to Endpoint in the sum of items of the
MMSE from Baseline to 12 month visit
- Mean change of Modified Isaacs test score from Baseline to
Endpoint
- Mean change of California Verbal Learning Test score from
Baseline to 12 month visit
- Mean change of time to perform the Trail Making Test A and B and
number of errors from Baseline to 12 month visit
- Mean change of Benton Visual Retention scorefrom Baseline to 12
month visit
- Mean change of McNair scorefrom Baseline to 12 month visit

About Aricept(R) (donepezil)

Aricept is an acetylcholinesterase inhibitor (AChEI) licensed in
the European Union for the symptomatic treatment of mild to
moderately severe Alzheimer's dementia.

About mild cognitive impairment[6]

Mild cognitive impairment represents an intermediate state of
cognitive function between the changes seen in aging and those
fulfilling the criteria for dementia and often Alzheimer's disease.

About Alzheimer's disease

Alzheimer's disease is the most common form of dementia. This
irreversible, progressive brain disorder gradually destroys memory,
reasoning and thinking skills, and may eventually leave patients
unable to carry out even the simplest tasks.[7] Dementia currently
5.4 million people in the EU, and is estimated to cost the EU economy
EUR160 billion per year, of which 55% is informal care provided by
family members, friends or volunteers.[8]

About Eisai

Eisai is one of the world's leading Research & Development-based
pharmaceutical companies that has defined its corporate mission as
"giving first thought to patients and their families and to
increasing the benefits health care provides," which we call human
health care (hhc).

Eisai concentrates its Research & Development activities in three
key areas:

- Neuroscience: Alzheimer's disease, multiple sclerosis,
neuropathic pain, epilepsy, depression
- Oncology: Anticancer therapies; tumour regression, tumour
suppression, antibodies, and supportive cancer therapies; pain relief,
nausea
- Vascular/Immunological Reaction: Acute coronary syndrome,
atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis,
Crohn''s disease

With operations in the U.S., Asia, Europe and its domestic home
market of Japan, we employ more than 10,000 people worldwide, and
reported consolidated sales of over GBP3.53 billion in FY2007, an
increase of 8.9% year on year. In Europe, Eisai undertakes sales and
marketing operations in over 20 markets, including the United
Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland,
Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic,
Hungary, Slovakia and the Netherlands.

For further information please visit our web site
http://www.eisai.com

About Pfizer: Working Together for a Healthier World(TM)

At Pfizer, we apply science and our global resources to improve
health and well-being at every stage of life. We strive to set the
standard for quality, safety and value in the discovery, development
and manufacturing of medicines for people and animals. Our
diversified global health care portfolio includes human and animal
biologic and small molecule medicines and vaccines, as well as
nutritional products and many of the world''s best-known consumer
products. Every day, Pfizer colleagues work to advance wellness,
prevention, treatments and cures that challenge the most feared
diseases of our time. Consistent with our responsibility as the
world's leading biopharmaceutical company, we also collaborate with
health care providers, governments and local communities to support
and expand access to reliable, affordable health care around the
world. For more than 150 years, Pfizer has worked to make a
difference for all who rely on us.

For further information please visit our web site:
http://www.pfizer.com

References:

1. Eisai Data on File (ICAD Abstract Presentation)

2. Aricept SPC: Available from
http://www.medicines.org.uk/emc/medicine/577/SPC/ (Last updated 27
July 2010)

3. Burgess, N. The hippocampus, space, and viewpoints in episodic
memory. The Quarterly Journal of Experimental Psychology 2002, 55A
(4), 1057 - 1080

4. Yavuz BB, Ariogul S, Cankurtaran M, Oguz KK, Halil M, Dagli N,
Cankurtaran ES. Hippocampal atrophy correlates with the severity of
cognitive decline. Int Psychogeriatr 2007 19 (4): 767 -77

5. Dubois, B. et al. Revising the definition of Alzheimer''s
disease: a new lexicon. The Lancet Neurology (2010), (9) 1118 -- 1127

6. Petersen, R. Mild cognitive impairment. NEJM (2011) 364: 2227
-- 2234

7. National Institute on Aging (NIA). Alzheimer''s Disease
Factsheet. NIH Publication No 08-6423. Reprinted February 2010

8. Alzheimer Europe: European Collaboration on Dementia: Cost of
illness and burden of dementia: Anders Wimo, Karolinska Institutet,
Linus Jönsson, I3 Innovus and Anders Gustavsson, Senior Analyst, I3
Innovus. Available at URL: http://www.alzheimer-europe.org/Our-Resear
ch/European-Collaboration-on-Dementia/Cost-of-dementia/Cost-of-illnes
s-and-burden-of-dementia Last accessed July 2011

ots Originaltext: Eisai Europe Ltd AND Pfizer Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: Benjamyn Tan / GurjitHothi,
Tonic Life Communications, +44-(0)-774-7111-217 /+44-(0)207-798-9900,
Benjamyn.tan@toniclc.com / Aricept@toniclc.com; EisaiEurope Ltd,
Cressida Robson: +44-(0)-7908-314-155; Pfizer Press Office:
+44-(0)-845-300-8033