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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Escitalopram escitalopram 20mg qd
Placebo placebo 20mg qd

Participant Flow:   Overall Study
    Escitalopram   Placebo
STARTED   37   37 
COMPLETED   28   29 
NOT COMPLETED   9   8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Escitalopram escitalopram 20mg qd
Placebo placebo 20mg qd
Total Total of all reporting groups

Baseline Measures
   Escitalopram   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   29   57 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.33  (7.12)   74.82  (9.19)   74.58  (8.17) 
Gender 
[Units: Participants]
     
Female   15   21   36 
Male   13   8   21 


  Outcome Measures

1.  Primary:   % Change of Hippocampus Volume   [ Time Frame: 52 weeks ]

2.  Primary:   % Change of Whole Brain Volume   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: howlow44@daum.net



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