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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | Escitalopram 20mg tablet by mouth once a day |
|
| Placebo | Placebo Comparator | Placebo 20mg tablet by mouth once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug | 5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period) |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Change of Hippocampus Volume | 52 weeks | |
| % Change of Whole Brain Volume | 52 weeks |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong Young Lee, MD, PhD | Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine | Principal Investigator |
| Jong Inn Woo, MD, PhD | Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangwon National University Hospital | Chuncheon | South Korea | ||||
| Seoul National University Bundang Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Escitalopram | escitalopram 20mg qd |
| FG001 | Placebo | placebo 20mg qd |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | escitalopram 20mg qd |
| BG001 | Placebo | placebo 20mg qd |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % Change of Hippocampus Volume | The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis. | Posted | Mean | Standard Deviation | percentage of change | 52 weeks |
|
|
Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Escitalopram | Escitalopram 20mg qd |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jaundice | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Min Choe | Seoul National University Hospital | 82-2-2072-1730 | howlow44@daum.net |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| 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 | 5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period) |
|
| Seongnam |
| South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Konkuk University Hospital | Seoul | South Korea |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | % Change of Whole Brain Volume | The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis. | Posted | Mean | Standard Deviation | percentage of change | 52 weeks |
|
|
|
| 2 |
| 37 |
| 13 |
| 37 |
| EG001 | Placebo | Placebo 20mg qd | 3 | 37 | 7 | 37 |
| Death by traffic accident | Social circumstances | Systematic Assessment |
|
| Cerebral hemorrhage | Vascular disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| somnolence | General disorders | Systematic Assessment |
|
| tremor | Nervous system disorders | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| violent behavior | Psychiatric disorders | Systematic Assessment |
|
| urinary incontinence | Renal and urinary disorders | Systematic Assessment |
|
| hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |