Progression Delaying Effect of Escitalopram in Alzheimer's Disease

NCT ID: NCT00702780

Last Updated: 2014-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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* 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)

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Escitalopram

Escitalopram 20mg tablet by mouth once a day

Group Type EXPERIMENTAL

escitalopram

Intervention Type 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)

Placebo

Placebo 20mg tablet by mouth once a day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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)

Interventions

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escitalopram

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)

Intervention Type DRUG

placebo

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)

Intervention Type DRUG

Other Intervention Names

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Lexapro

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lundbeck A/S

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Young Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong Young Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine

Jong Inn Woo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine

Locations

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Kangwon National University Hospital

Chuncheon, , South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Konkuk University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUDC001

Identifier Type: -

Identifier Source: org_study_id

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