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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00702780
First received: June 15, 2008
Last updated: July 15, 2011
Last verified: July 2011
History of Changes
  Purpose

The purpose of this study is to verify the progression delaying effect of escitalopram in Alzheimer's disease using volumetric MRI change as a primary outcome measure.


Condition Intervention
Alzheimer's Disease
 Drug: escitalopram
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • % change of hippocampal and whole brain volume [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognition: ADAD-cog (Alzheimer's Disease Assessment Scale-cognitive subscale), MMSE (Mini-Mental State Examination) Neuropsychiatric symptoms: NPI (Neuropsychiatric Inventory), CSDD (Cornell Scale for Depression in Dementia) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: November 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
escitalopram 20mg p.o. (5mg for 2weeks, 10mg for 2weeks, and 20mg for 48weeks)
 Drug: escitalopram
5mg/day for 2weeks, 10mg/day for 2weeks and 20mg/day for 48weeks (maintaining donepezil at the previous stable dose during the whole trial period)
Other Name: Lexapro
Placebo Comparator: 2
Placebo
 Drug: placebo
5mg/day for 2weeks, 10mg/day for 2weeks and 20mg/day for 48weeks (maintaining donepezil at the previous stable dose during the whole trial period)
Other Name: placebo

Detailed Description:
  • Study institutions: Four university hospitals in Korea
  • Design:52 week, randomized, placebo-controlled, double-blind, parallel group design
  • Subjects:80 probable Alzheimer's disease patients who have been taking donepezil at stable dose for at least 2 months (Escitalopram 40 : Placebo 40)
  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702780

Locations
Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Konkuk University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
H. Lundbeck A/S
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Dong Young Lee / Associate Professor of Neuropsychiatry, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00702780     History of Changes
Other Study ID Numbers: SNUDC001
Study First Received: June 15, 2008
Last Updated: July 15, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Alzheimer's disease
escitalopram
MRI

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013