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N/A N=74 Randomized Quadruple-blind Treatment

Progression Delaying Effect of Escitalopram in Alzheimer's Disease

Alzheimer's Disease

Enrolled (actual)
74
Serious AEs
6.8%
Results posted
Jun 2014
Primary outcome: Primary: % Change of Hippocampus Volume — -7.63; -7.28 percentage of change

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
escitalopram (Drug); placebo (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Seoul National University Hospital
Primary completion
Sep 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
% Change of Hippocampus Volume
-7.63; -7.28
PRIMARY
% Change of Whole Brain Volume
-3.27; -2.30

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.

Eligibility 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
  • Evidence of focal brain lesions on MRI including lacunes and white matter hyperintensity lesions of grade 2 or more by Fazeka scale
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00702780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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