Progression Delaying Effect of Escitalopram in Alzheimer's Disease - Full Text View

Sponsors and Collaborators:	Seoul National University Hospital H. Lundbeck A/S
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00702780

Purpose

The purpose of this study is to verify the progression delaying effect of escitalopram in Alzheimer's disease using volumetric MRI change as a primary outcome measure.

Condition	Intervention
Alzheimer's Disease	Drug: escitalopram Drug: placebo

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multi-Center, Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

% change of hippocampal and whole brain volume [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cognition: ADAD-cog (Alzheimer's Disease Assessment Scale-cognitive subscale), MMSE (Mini-Mental State Examination) Neuropsychiatric symptoms: NPI (Neuropsychiatric Inventory), CSDD (Cornell Scale for Depression in Dementia) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental escitalopram 20mg	Drug: escitalopram 5mg/day for 2weeks, 10mg/day for 2weeks and 20mg/day for 48weeks (maintaining donepezil at the previous stable dose during the whole trial period)
2: Placebo Comparator Placebo	Drug: placebo 5mg/day for 2weeks, 10mg/day for 2weeks and 20mg/day for 48weeks (maintaining donepezil at the previous stable dose during the whole trial period)

Detailed Description:

Study institutions: Four university hospitals in Korea
Design:52 week, randomized, placebo-controlled, double-blind, parallel group design
Subjects:80 probable Alzheimer's disease patients who have been taking donepezil at stable dose for at least 2 months (Escitalopram 40 : Placebo 40)

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702780

Contacts

Contact: Dong Young Lee, MD, PhD	82-2-2072-2205	selfpsy@snu.ac.kr
Contact: IL Han Choo, MD, PhD	82-2-2072-1630	npchoo10@snu.ac.kr

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-744
Contact: IL Han Choo, MD, PhD +82-2-2072-1630 npchoo10@snu.ac.kr
Principal Investigator: Jong Inn Woo, MD, PhD
Seoul National University Bundang Hospital	Active, not recruiting
Seongnam, Korea, Republic of
Kangwon National University Hospital	Active, not recruiting
Chuncheon, Korea, Republic of
Konkuk University Hospital	Active, not recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

H. Lundbeck A/S

Investigators

Principal Investigator:	Dong Young Lee, MD, PhD	Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Principal Investigator:	Jong Inn Woo, MD, PhD	Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine

More Information

No publications provided

Responsible Party:	Seoul National University Hospital ( Dong Young Lee / Associate Professor of Neuropsychiatry )
Study ID Numbers:	SNUDC001
Study First Received:	June 15, 2008
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00702780 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Alzheimer's disease
escitalopram
MRI

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Alzheimer Disease
Psychotropic Drugs
Disease Progression
Central Nervous System Diseases
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases
Serotonin Uptake Inhibitors
Citalopram
Serotonin

Cognition Disorders
Muscarinic Antagonists
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Dementia
Dexetimide
Antidepressive Agents
Delirium

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Neurodegenerative Diseases
Brain Diseases
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation

Dexetimide
Dementia
Antidepressive Agents
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Autonomic Agents
Peripheral Nervous System Agents
Tauopathies

ClinicalTrials.gov processed this record on May 07, 2009