Alzheimer's DiseaseESADNCT00702780
Progression Delaying Effect of Escitalopram in Alzheimer's Disease
A study testing escitalopram in people with Alzheimer's Disease, run by Seoul National University Hospital at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Nov 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Kangwon National University Hospital
Chuncheon
Seoul National University Bundang Hospital
Seongnam
Seoul National University Hospital
Seoul, 110-744
Konkuk University Hospital
Seoul
About this study
Official title: Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.
Read the 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)
- Conditions
- Alzheimer's Disease
- Being tested
- escitalopram, placebo
- Keywords
- Alzheimer's disease, escitalopram, MRI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
escitalopramDrug
Also called Lexapro
5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
placeboDrug
5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram | Experimental | Escitalopram 20mg tablet by mouth once a day Receives: Drug: escitalopram |
| Placebo | Placebo comparator | Placebo 20mg tablet by mouth once a day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change of Hippocampus Volume
Measured: 52 weeks
% Change of Whole Brain Volume
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lundbeck A/S
- Responsible party
- Principal investigator, Dong Young Lee, Seoul National University Hospital
- Investigators
- Dong Young Lee, MD, PhD, Principal investigator, Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of MedicineJong Inn Woo, MD, PhD, Principal investigator, Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702780
- Sponsor's protocol ID
- SNUDC001
- Acronym
- ESAD
- Status last verified
- May 2014
- First submitted
- 15 Jun 2008
- Last updated
- 13 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00702780
- Acronym / sponsor ID
- ESAD / SNUDC001
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, escitalopram, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- H. Lundbeck A/S
- Study start
- Nov 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Posted 13 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Escitalopram | Experimental | Drug: escitalopramEscitalopram 20mg tablet by mouth once a day |
| Placebo | Placebo comparator | Drug: placeboPlacebo 20mg tablet by mouth once a day |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| escitalopramAlso: Lexapro5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period) | Drug | Escitalopram |
| placebo5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period) | Drug | Placebo |
Primary outcome
% Change of Hippocampus Volume
Time frame: 52 weeks
% Change of Whole Brain Volume
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Young Lee, MD, PhD principal investigator
Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Jong Inn Woo, MD, PhD principal investigator
Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing escitalopram in people with Alzheimer's Disease, run by Seoul National University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Change of Hippocampus Volume (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.