The purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
351
Subjects in the Group-10 mg: Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg
Subjects in the Group-23 mg: Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg
The Severe Impairment Battery (SIB)
SIB: change from Baseline to Week 24 in the total SIB score - Last Observation Carried Forward (LOCF)
Time frame: 24 weeks
The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)
CIBIC+: overall change score at Week 24 - Last Observation Carried Forward (LOCF)
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Anjo, Aichi-ken, Japan
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Ōbu, Aichi-ken, Japan
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Toyoake, Aichi-ken, Japan
Unnamed facility
Chikushi, Fukuoka, Japan
Unnamed facility
Kitakyushu, Fukuoka, Japan
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Fukuoka, Gunma, Japan
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Miyoshi, Hiroshima, Japan
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Ōtake, Hiroshima, Japan
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Amagasaki, Hyōgo, Japan
Unnamed facility
Himeji, Hyōgo, Japan
...and 44 more locations