A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00884507
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
389 participants
INTERVENTIONAL
2009-05-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
po daily for 24 weeks
RO5313534 15mg
RO5313534
15mg po daily for 24 weeks
RO5313534 1mg
RO5313534
1mg po daily for 24 weeks
RO5313534 5mg
RO5313534
5mg po daily for 24 weeks
Interventions
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Placebo
po daily for 24 weeks
RO5313534
1mg po daily for 24 weeks
RO5313534
5mg po daily for 24 weeks
RO5313534
15mg po daily for 24 weeks
Eligibility Criteria
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Inclusion Criteria
* probable Alzheimer's disease;
* MMSE score at screening of 13-22;
* under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for \>=4 months prior to baseline;
* not requiring nursing home care, but looked after by a caregiver/carer.
Exclusion Criteria
* other significant neurological disorder;
* untreated/non-stabilized major depressive disorder;
* bipolar disorder, schizophrenia, or any other serious psychiatric condition.
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Orange, California, United States
Torrance, California, United States
Norwalk, Connecticut, United States
Delray Beach, Florida, United States
Fort Myers, Florida, United States
Maitland, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Paducah, Kentucky, United States
Kalamazoo, Michigan, United States
Creve Coeur, Missouri, United States
Eatontown, New Jersey, United States
Albuquerque, New Mexico, United States
White Plains, New York, United States
Portland, Oregon, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Caba, , Argentina
Hornsby, New South Wales, Australia
Chermside, Queensland, Australia
Woodville, South Australia, Australia
Medicine Hat, Alberta, Canada
Vancouver, British Columbia, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Verdun, Quebec, Canada
Regina, Saskatchewan, Canada
Montpellier, , France
Nice, , France
Saint-Herblain, , France
Toulouse, , France
Günzburg, , Germany
Leipzig, , Germany
München, , Germany
Nuremberg, , Germany
Napoli, Campania, Italy
Castellanza, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Aguascalientes, , Mexico
Guadalajara, , Mexico
Monterrey, , Mexico
Saltillo, , Mexico
Gdansk, , Poland
Leszno, , Poland
Torun, , Poland
Warsaw, , Poland
Bucharest, , Romania
Bucharest, , Romania
Bratislava, , Slovakia
Michalovce, , Slovakia
Barcelona, Barcelona, Spain
BArcelon, Barcelona, Spain
Salt, Girona, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Barakaldo, Vizcaya, Spain
Blackpool, , United Kingdom
Bradford, , United Kingdom
Glasgow, , United Kingdom
Southampton, , United Kingdom
Countries
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Other Identifiers
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2008-004012-13
Identifier Type: -
Identifier Source: secondary_id
WN22018
Identifier Type: -
Identifier Source: org_study_id