Progression Delaying Effect of Escitalopram in Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— ESAD  

Official title:

Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702780
• Other study ID #: SNUDC001
• Status: Completed
• Phase: N/A
• First received: June 15, 2008
• Last updated: May 13, 2014
• Start date: November 2008
• Est. completion date: September 2011

Study information

• Verified date: May 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	H. Lundbeck A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Change of Hippocampus Volume		52 weeks	No
Primary	% Change of Whole Brain Volume		52 weeks	No