Purpose : to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease Trial Design : A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial with an open-label, 12-week extension
Clinical trial agreement signed by the parties to the subjects through a process of screening. if it is consider suitable for evaluating through the selection / exclusion criteria, they will be randomly assigned to the test group or control group (placebo). Assigned to the test group or control subjects, they will be prescribe the 5mg Escitalopram or Placebo. without regard to meals, it will be taking once a day. and than It should be increased the capacity every two weeks by 5mg/day up to a maximum 15mg/day. and than, on the treatment for a 8 weeks, If you don't find the side effect, Maintaining the same capacity. If you find the side effect, you should lose capacity.(10mg/day) The test group or control subjects, will receive a doctor's examination and inspection through six visits for a 24weeks from the date of the randomly assigned participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
escitalopram 15mg, QD(once a day), Oral medication, 24weeks
placebo 15mg, QD(once a day), Oral medication
MedicalExcellence
Seoul, Secho-gu Banpo-dong, South Korea
Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups
Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups.
Time frame: 12 weeks
Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.
Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.
Time frame: 24weeks
Change from baseline in K-MMSE at week 12 and 24.
Change from baseline in K-MMSE at week 12 and 24.
Time frame: 24 weeks
Change from baseline in ADAS-Cog at week 12 and 24.
Change from baseline in ADAS-Cog at week 12 and 24.
Time frame: 24 weeks
Change from baseline in NPIQ at week 12 and 24.
Change from baseline in NPIQ at week 12 and 24.
Time frame: 24 weeks
Change from baseline in S-IADL at week 12 and 24.
Change from baseline in S-IADL at week 12 and 24.
Time frame: 24 weeks
Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.
Change from baseline in GDS-15 at week 4, 8, 12, 16 and 24.
Time frame: 24 weeks
Change from baseline in CDR at week 12 and 24.
Change from baseline in CDR at week 12 and 24.
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Time frame: 24 weeks
Change from baseline in CDR sum of box at week 12 and 24.
Change from baseline in CDR sum of box at week 12 and 24.
Time frame: 24 weeks
Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.
Change from baseline in Pittsburgh Sleep Quality Index at week 12 and 24.
Time frame: 24 weeks