Evaluation of the safety and tolerability of a 20 mg once daily dose of memantine compared with 10 mg given twice daily in patients with dementia of Alzheimer's type and MMSE range 5-18.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
CN001
Beijing, China
CN006
Fujian, China
CN004
Shandong, China
CN002
Tianjin, China
CN007
Xi'an, China
Adverse Events
Number of patients who reported adverse events
Time frame: baseline to week 16 (end of study)
ADCS - CGIC Score at Week 12
The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) is a semi-structured interview designed to assess clinically relevant changes in patients with Alzheimer's disease. Items in the ADCS-CGIC interview provide general information, and information about cognition, behaviour, social and daily functioning. Responses to ADCS-CGIC interview result in a global clinical judgement of severity (at baseline) and clinically relevant change at subsequent visits. Severity rated at baseline is only used for reference. The severity at baseline is rated on a 7-point Likert-type scale from 1(normal, not ill at all) to 7 (among the most extremely ill patients). The ADCS-CGIC relevant change is rated on a 7-point Likert-type scale from 1 (marked improvement) to 7 (marked worsening).
Time frame: ADCS - CGIC score at Week 12
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CN003
Zhejiang, China