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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| escitalopram | Experimental | escitalopram 15mg |
|
| Placebo | Placebo Comparator | placebo 15mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug | escitalopram 15mg, QD(once a day), Oral medication, 24weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24weeks |
| Change from baseline in K-MMSE at week 12 and 24. |
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Inclusion Criteria:
1) over the age of 50
2) Medical diagnostic criteria must meet the standard.
3) When screening, Cholinesterase inhibitors taking a minimum of four weeks or more stable subject.
4) During the clinical trials, Subject does not change the capacity of Cholinesterase Inhibitors.
5) MRI or CT results within 24 months of subject with Alzheimer's disease (AD)
6) Participation in clinical trials to determine their own and written informed consent form and subject who actively perform clinical procedure including the questionnaire. But the subjects with cognitive dysfunction that cannot voluntarily make the decision, can be determined by an authorized representative to participate in.
7) Subjects must be accompanied their guardian to every visit. More than three days a week, more than 4 hours per day, spend the day with the guardian.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seol-Heui HAN, Professor | Kunkuk Universicy Hospital | Principal Investigator |
| Dong-Won YANG, Professor | Seoul St. Mary's Hospital | Principal Investigator |
| Sung-Yoon KIM, Professor | Asan Medical Center | Principal Investigator |
| Kun-Woo PARK, Professor | Korea University Hospital | Principal Investigator |
| Do-Hoon KIM, Professor | Hanlym University Hospital | Principal Investigator |
| So-Young MUN, Professor | AJU University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedicalExcellence | Seoul | Secho-gu Banpo-dong | 505 | South Korea |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Placebo | Drug | placebo 15mg, QD(once a day), Oral medication |
|
Change from baseline in K-MMSE at week 12 and 24. |
| 24 weeks |
| Change from baseline in ADAS-Cog at week 12 and 24. | Change from baseline in ADAS-Cog at week 12 and 24. | 24 weeks |
| Change from baseline in NPIQ at week 12 and 24. | Change from baseline in NPIQ at week 12 and 24. | 24 weeks |
| Change from baseline in S-IADL at week 12 and 24. | Change from baseline in S-IADL at week 12 and 24. | 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. | 24 weeks |
| Change from baseline in CDR at week 12 and 24. | Change from baseline in CDR at week 12 and 24. | 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. | 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. | 24 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019964 | Mood Disorders |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |