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04.03.2005 – 23:30

AstraZeneca GmbH

Study Finds Seroquel Effective And Well Tolerated In Elderly Patients With Alzheimer's Disease

    Alderley Park, UK (ots)

AstraZeneca announced results from a
study involving elderly patients with Alzheimer's disease (AD)
treated with the atypical antipsychotic SEROQUEL (quetiapine) today
at the annual meeting of the American Association of Geriatric
Psychiatry in San Diego, USA. The study found that SEROQUEL at 200
mg/day was effective in reducing agitation in elderly patients with
AD without leading to a decline in cognitive function. SEROQUEL was
also generally well tolerated with no incidence of cerebrovascular
adverse events during treatment, which have been associated with the
use of other atypical antipsychotics in this patient population. (1)
Inthe 30-day follow up, one cerebrovascular event was reported in the
100 mg/day group.
    
    The trial studied a sub-group of Alzheimer's disease patients from
the STAR study. The primary goal of the STAR clinical trial was to
examine elderly patients with dementia, including Alzheimer's disease
and vascular dementia.  
    
    Dementia is a term for various progressive brain disorders, the
most common being Alzheimer's disease, vascular dementia and dementia
with Lewy bodies, that result in a loss of brain function. Symptoms
of dementia include memory loss, problems with reasoning, judgement
and speech, and the inability to perform everyday tasks.(2)
Behavioural disturbances, including agitation, have been reported in
up to 90% of patients with dementia, which can result in patients
becoming distressed and aggressive, putting an immense strain on
caregivers and affecting their ability to care for the individuals.
(3), (4)
    
    "Agitation is a significant issue for both patients and their
carers, as it is both difficult to manage and can be emotionally
troubling," said Pierre Tariot, M.D., Professor of Psychiatry,
Medicine and Neurology at the University of Rochester. "This new
sub-group analysis in Alzheimer's patients adds further weight to the
results from the STAR study released last year and justifies the
continued investigation of SEROQUEL for agitation in this patient
population."
      
    The Alzheimer's analysis was from a 10-week, double-blind,
placebo-controlled trial and included 260 patients with AD who were
randomised to receive SEROQUEL 200mg/day, SEROQUEL 100mg/day or
placebo. The key efficacy measures were improvements in the Positive
and Negative Syndrome Scale-Excitement Component (PANSS-EC) scale,
designed to measure symptoms such as hostility, tension and
excitement; and the Clinicians' Global Impression of Change (CGI-C)
scale, designed to enable clinicians to rate the level of improvement
in symptoms. Cognitive decline was assessed using the Mini Mental
State Examination (MMSE).  The trial results showed(1):
    
    * AD patients receiving SEROQUEL 200mg/day experienced
significantly reduced symptoms of agitation compared to placebo as
measured by PANSS-EC scores (p<0.05) and CGI-C scores (p<0.05)
    
    * A significantly greater percentage of AD patients receiving
SEROQUEL (200mg/day) were rated "much improved" or "very much
improved" in CGI-C scores (54%) compared with those in the placebo
group (26%) (p<0.01)
    
    * Significantly more AD patients receiving SEROQUEL 200mg/day
exhibited a * 40% reduction in PANSS-EC scores compared to placebo
(p<0.05)
    
    * Completion rates among AD patients was similar across the three
groups: 67%, 66% and 63% for SEROQUEL 200mg/day, 100mg/day and
placebo, respectively
    
    * The mean (+/- Standard Deviation) changes from baseline in MMSE
for SEROQUEL 200 mg/d, 100 mg/d and placebo were 0.2 (+/- 2.6), -0.2
(+/- 2.8), and    -0.1 (+/- 2.0), respectively, indicating no
worsening of cognitive function in this patient population.
    
    "Due to the progressive nature of Alzheimer's disease, the ability
to manage agitation without causing a decline in cognitive function
is of notable clinical importance," added Tariot.
    
    SEROQUEL has been licensed for the treatment of schizophrenia
since 1997 and is available in 82 countries for the treatment of this
condition. SEROQUEL is also licensed in 63 countries for the
treatment of mania associated with bipolar disorder, including the
US, Canada and several European countries. SEROQUEL has not been
approved for the treatment of agitation in Alzheimer's disease
patients. To date, over 8 million people have been treated with
SEROQUEL worldwide.  
    
    AstraZeneca is a major international healthcare business engaged
in the research, development, manufacture and marketing of
prescription pharmaceuticals and the supply of healthcare services.
It is one of the world's leading pharmaceutical companies with
healthcare sales of over $21.4 billion and leading positions in sales
of gastrointestinal, cardiovascular, respiratory, oncology and
neuroscience products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
    
    In Neuroscience, AstraZeneca is dedicated to providing medicines
that have the potential to change patients' lives. The company
already markets several products including SEROQUEL, one of the
fastest growing global antipsychotics with proven efficacy and a very
favourable side effect profile; and ZOMIG, a reliable migraine
therapy and a leader within the triptan market. The Neuroscience
pipeline includes leading approaches for the treatment of depression
and anxiety, overactive bladder, dementia, stroke, pain control and
anaesthesia.
    
    For more information, please visit www.astrazenecapressoffice.com
    
    - ends -
    
    SEROQUEL is a trade mark of the AstraZeneca group of companies.
    
    EDITOR'S NOTE:  SEROQUEL has not been approved for the treatment
of agitation in Alzheimer's Disease patients.  

    References:          1. Zhong, K. Quetiapine Treatment of Behavioral Disturbance in Patients with Alzheimer's Disease. Presented at the American Association of Geriatric Psychiatry, San Diego, USA, 2005          2. Alzheimer's Society - Dementia Care and Research: Facts about dementia http://www.alzheimers.org.uk/Facts_about_dementia/index.htm          3. Brodaty H et al. Psychosis, depression and behavioural disturbances in Sydney nursing home residents: prevalence and predictors. Int J Geriatr Psychiatry 2001;16:504-512          4. Alzheimer's Society Caring for someone with dementia - unusual behaviour http://www.alzheimers.org.uk/Caring_for_someone_with_dementia/Unusual _behaviour/advice_aggressive.htm

    For further information, please visit www.astrazenecapressoffice.com or please contact:      Carla Burigatto at AstraZeneca Tel: +1 302 886 5953 Mobile: +1 610 457 2178 carla.burigatto@astrazeneca.com      Louise Marland at AstraZeneca Tel: +44 (0)1625 510 782 Mobile: +44 (0)7900 607 794 louise.marland@astrazeneca.com      Sarah Fraser at Shire Health International Mobile: +1 917 945 7488 sarah.fraser@newyork.shirehealth.com

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