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Progression Delaying Effect of Escitalopram in Alzheimer's Disease

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Disease

Intervention: escitalopram (Drug); placebo (Drug)

Phase: N/A

Status: Completed

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

Summary

This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

% Change of Hippocampus Volume

% Change of Whole Brain Volume

Detailed description:

- Study institutions: Four university hospitals in Korea

- Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial

- Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at

stable dose within 2 months (Escitalopram 37 : Placebo 37)

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

- Evidence of focal brain lesions on MRI including lacunes and white matter

hyperintensity lesions of grade 2 or more by Fazeka scale

Locations and Contacts

Kangwon National University Hospital, Chuncheon, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, Korea, Republic of

Konkuk University Hospital, Seoul, Korea, Republic of

Seoul National University Hospital, Seoul 110-744, Korea, Republic of

Additional Information

Starting date: November 2008
Last updated: May 13, 2014

Page last updated: August 23, 2015

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