Clinical trial NCT00702780: Progression Delaying Effect of Escitalopram in Alzheimer's Disease
Official title: Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
escitalopram
MRI
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2008-06-20
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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)

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

Primary outcomes:
measure: % Change of Hippocampus Volume
timeFrame: 52 weeks
measure: % Change of Whole Brain Volume
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
Study officials:
affiliation: Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
name: Dong Young Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
name: Jong Inn Woo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: