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

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ClinicalTrials.gov Identifier: NCT00702780
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Dong Young Lee, Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Disease
Interventions Drug: escitalopram
Drug: placebo
Enrollment 74
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description escitalopram 20mg qd placebo 20mg qd
Period Title: Overall Study
Started 37 37
Completed 28 29
Not Completed 9 8
Arm/Group Title Escitalopram Placebo Total
Hide Arm/Group Description escitalopram 20mg qd placebo 20mg qd Total of all reporting groups
Overall Number of Baseline Participants 28 29 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 57 participants
74.33  (7.12) 74.82  (9.19) 74.58  (8.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Female
15
  53.6%
21
  72.4%
36
  63.2%
Male
13
  46.4%
8
  27.6%
21
  36.8%
1.Primary Outcome
Title % Change of Hippocampus Volume
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
escitalopram 20mg qd
placebo 20mg qd
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: percentage of change
-7.63  (7.32) -7.28  (5.76)
2.Primary Outcome
Title % Change of Whole Brain Volume
Hide Description [Not Specified]
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed for per-protocol (PP) population, which included participants who had both baseline and follow-up MRI scan suitable for analysis.
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description:
escitalopram 20mg qd
placebo 20mg qd
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: percentage of change
-3.27  (2.69) -2.30  (3.08)
Time Frame Baseline, and 2, 4, 8, 16, 28, 40, 52 weeks after baseline.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Escitalopram Placebo
Hide Arm/Group Description Escitalopram 20mg qd Placebo 20mg qd
All-Cause Mortality
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/37 (5.41%)   3/37 (8.11%) 
Gastrointestinal disorders     
Vomiting   0/37 (0.00%)  1/37 (2.70%) 
Hepatobiliary disorders     
Jaundice   1/37 (2.70%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia   0/37 (0.00%)  1/37 (2.70%) 
Social circumstances     
Death by traffic accident   1/37 (2.70%)  0/37 (0.00%) 
Vascular disorders     
Cerebral hemorrhage   0/37 (0.00%)  1/37 (2.70%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Escitalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/37 (35.14%)   7/37 (18.92%) 
Endocrine disorders     
hypoglycemia   1/37 (2.70%)  0/37 (0.00%) 
Gastrointestinal disorders     
vomiting   0/37 (0.00%)  1/37 (2.70%) 
anorexia   1/37 (2.70%)  1/37 (2.70%) 
abdominal pain   0/37 (0.00%)  1/37 (2.70%) 
diarrhea   1/37 (2.70%)  0/37 (0.00%) 
constipation   0/37 (0.00%)  1/37 (2.70%) 
General disorders     
somnolence   1/37 (2.70%)  0/37 (0.00%) 
Injury, poisoning and procedural complications     
fall   0/37 (0.00%)  1/37 (2.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
cancer   1/37 (2.70%)  1/37 (2.70%) 
Nervous system disorders     
dizziness   4/37 (10.81%)  0/37 (0.00%) 
tremor   1/37 (2.70%)  0/37 (0.00%) 
Psychiatric disorders     
violent behavior   1/37 (2.70%)  0/37 (0.00%) 
Renal and urinary disorders     
urinary incontinence   1/37 (2.70%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
cough   1/37 (2.70%)  0/37 (0.00%) 
bronchitis   0/37 (0.00%)  1/37 (2.70%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Young Min Choe
Organization: Seoul National University Hospital
Phone: 82-2-2072-1730
Responsible Party: Dong Young Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00702780     History of Changes
Other Study ID Numbers: SNUDC001
First Submitted: June 15, 2008
First Posted: June 20, 2008
Results First Submitted: April 10, 2014
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014