Progression Delaying Effect of Escitalopram in Alzheimer's Disease

NCT00702780 | Completed Results DMC

• 1 other identifier: SNUDC001
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease; escitalopram; MRI

Outcome Measures

Primary Outcomes (2)

• % Change of Hippocampus Volume

  52 weeks

• % Change of Whole Brain Volume

  52 weeks

Study Arms (2)

Escitalopram

EXPERIMENTAL

Escitalopram 20mg tablet by mouth once a day

Drug: escitalopram

Placebo

PLACEBO COMPARATOR

Placebo 20mg tablet by mouth once a day

Drug: placebo

Interventions

escitalopram 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)

Also known as: Lexapro

Escitalopram

placebo 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)

Placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• H. Lundbeck A/S: collaborator

Study Sites (4)

Kangwon National University Hospital

Chuncheon, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Konkuk University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Young Min Choe
• Organization: Seoul National University Hospital

howlow44@daum.net

82-2-2072-1730

Study Officials

• Dong Young Lee, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Jong Inn Woo, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2008
• First Posted: June 20, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 13, 2014
• Results First Posted: June 13, 2014

Record last verified: 2014-05

Locations

KR (4)