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Completed

NCT Number: NCT00702780

Progression Delaying Effect of Escitalopram in Alzheimer's Disease

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangwon National University Hospital, Chuncheon, South Korea

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About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: Lexapro

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)

Primary outcomes

  1. % Change of Hippocampus Volume

    Time frame: 52 weeks

  2. % Change of Whole Brain Volume

    Time frame: 52 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study title

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

Acronym: ESAD

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2008
Registry last updated
Jun 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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