| June 15, 2008 |
| June 20, 2009 |
| November 2008 |
| November 2010 (final data collection date for primary outcome measure) |
| % change of hippocampal and whole brain volume [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00702780 on ClinicalTrials.gov Archive Site |
| Cognition: ADAD-cog (Alzheimer's Disease Assessment Scale-cognitive subscale), MMSE (Mini-Mental State Examination)
Neuropsychiatric symptoms: NPI (Neuropsychiatric Inventory), CSDD (Cornell Scale for Depression in Dementia) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ] |
| Same as current |
| |
| Progression Delaying Effect of Escitalopram in Alzheimer's Disease |
| Multi-Center, Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease |
The purpose of this study is to verify the progression delaying effect of escitalopram in Alzheimer's disease using volumetric MRI change as a primary outcome measure. |
- Study institutions: Four university hospitals in Korea
- Design:52 week, randomized, placebo-controlled, double-blind, parallel group design
- Subjects:80 probable Alzheimer's disease patients who have been taking donepezil at stable dose for at least 2 months (Escitalopram 40 : Placebo 40)
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| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Alzheimer's Disease |
- Drug: escitalopram
- Drug: placebo
|
- Experimental: escitalopram 20mg
- Placebo Comparator: Placebo
|
| |
| |
| Recruiting |
| 80 |
| November 2010 |
| November 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Age:40~90 years
- Education:not illiterate
- Clinical Dementia Rating (CDR):0.5~2
- Modified Hachinski Ischemic Score (Rosen et al., 1979):less than 4
- Dementia according to DSM-IV criteria
- Probable Alzheimer's disease according to NINCDS-ADRDA criteria
- Current ongoing donepezil medication at stable doses (5 ~ 10 mg/day) for at least 2 months
Exclusion criteria:
- Evidence of delirium, confusion or altered consciousness
- Evidence of Parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus
- Evidence of infectious or inflammatory brain disease
- Evidence of serious cerebrovascular diseases
- Current major depressive disorder or other major psychiatric illnesses
- Evidence of serious or unstable medical illnesses which can significantly change cognitive state
- History of alcohol or other substance dependence
- Any antidepressant medications within the previous 4 weeks
- Absence of a reliable and cooperative collateral informant
- Any conditions which prohibit MRI scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia
|
| Both |
| 40 Years to 90 Years |
| No |
|
|
| Korea, Republic of |
| |
| NCT00702780 |
| Dong Young Lee / Associate Professor of Neuropsychiatry, Seoul National University Hospital |
| SNUDC001 |
| Seoul National University Hospital |
| H. Lundbeck A/S |
| Principal Investigator: |
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 |
|
|
| Seoul National University Hospital |
| June 2009 |