Progression Delaying Effect of Escitalopram in Alzheimer's Disease (ESAD)

Seoul National University

Status: Completed

Conditions: Alzheimer's Disease

Treatments: Drug: placebo; Drug: escitalopram

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00702780

SNUDC001

Details and patient eligibility

About

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

Full 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)

Enrollment: 74 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 2 patient groups, including a placebo group

Escitalopram

Experimental group

Description:

Escitalopram 20mg tablet by mouth once a day

Treatment:

Drug: escitalopram

Placebo

Placebo Comparator group

Description:

Placebo 20mg tablet by mouth once a day

Treatment:

Drug: placebo