Progression Delaying Effect of Escitalopram in Alzheimer's Disease
Information source: Seoul National University Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease
Intervention: escitalopram (Drug); placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s):
Dong Young Lee, MD, PhD, Principal Investigator, Affiliation: Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Jong Inn Woo, MD, PhD, Principal Investigator, Affiliation: Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Overall contact:
Dong Young Lee, MD, PhD, Phone: 82-2-2072-2205, Email: selfpsy@snu.ac.kr
Summary
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.
Clinical Details
Official title: Multi-Center, Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: % change of hippocampal and whole brain volume
Secondary outcome: 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)
Detailed description:
- 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)
Eligibility
Minimum age: 40 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dong Young Lee, MD, PhD, Phone: 82-2-2072-2205, Email: selfpsy@snu.ac.kr
Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
IL Han Choo, MD, PhD, Phone: +82-2-2072-1630, Email: npchoo10@snu.ac.kr
Jong Inn Woo, MD, PhD, Principal Investigator
Seoul National University Bundang Hospital, Seongnam, Korea, Republic of; Active, not recruiting
Kangwon National University Hospital, Chuncheon, Korea, Republic of; Active, not recruiting
Konkuk University Hospital, Seoul, Korea, Republic of; Active, not recruiting
Additional Information
Starting date: November 2008
Ending date: November 2010
Last updated: November 14, 2008
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