Escitalopram for the Treatment of Depression in Alzheimer's Disease

NCT01841125 | Completed Phase 4

• 1 other identifier: ADD_E_2010
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose : to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease Trial Design : A 12-week, randomized, double-blind, parallel-group, placebo-controlled trial with an open-label, 12-week extension

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; depressive disorder

Outcome Measures

Primary Outcomes (1)

• Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups

  Change in CSDD(Cornell scale for depression in dementia) from baseline after 12 weeks of between treatment groups.

  12 weeks

Secondary Outcomes (9)

• Change from baseline in CSDD(Cornell scale for depression in dementia) at week 4, 8, 16 and 24.

  24weeks

• Change from baseline in K-MMSE at week 12 and 24.

  24 weeks

• Change from baseline in ADAS-Cog at week 12 and 24.

  24 weeks

• Change from baseline in NPIQ at week 12 and 24.

  24 weeks

• Change from baseline in S-IADL at week 12 and 24.

  24 weeks

Study Arms (2)

escitalopram

EXPERIMENTAL

escitalopram 15mg

Drug: escitalopram

Placebo

PLACEBO COMPARATOR

placebo 15mg

Drug: Placebo

Interventions

escitalopram DRUG

escitalopram 15mg, QD(once a day), Oral medication, 24weeks

Also known as: lexacure Tab

escitalopram

Placebo DRUG

placebo 15mg, QD(once a day), Oral medication

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) over the age of 50
• \) Medical diagnostic criteria must meet the standard.
• Subject diagnosed with Alzheimer's disease in accordance with NINCDS-ADRDA Criteria.
• Subject with three or more symptoms of the Olin depression (major depressive episode) diagnostic criteria.
• clinical dementia rating (CDR) of 0.5 to 2
• MMSE 10 \~ 26 (K-MMSE)
• GDS-15 ≥ 5 points
• \) When screening, Cholinesterase inhibitors taking a minimum of four weeks or more stable subject.
• \) During the clinical trials, Subject does not change the capacity of Cholinesterase Inhibitors.
• \) MRI or CT results within 24 months of subject with Alzheimer's disease (AD)
• \) Participation in clinical trials to determine their own and written informed consent form and subject who actively perform clinical procedure including the questionnaire. But the subjects with cognitive dysfunction that cannot voluntarily make the decision, can be determined by an authorized representative to participate in.
• \) Subjects must be accompanied their guardian to every visit. More than three days a week, more than 4 hours per day, spend the day with the guardian.

You may not qualify if:

• If you are taking other depression drugs within 4 weeks before the start of the clinical trials(e.g. SSRI, Stablon, TCA, wellbutrin, ixel)
• If you have any other mental illness (bipolar disorder, schizophrenia, etc.)
• If you have a serious medical illness (heart failure, angina pectoris, myocardial infarction, arteriosclerosis, etc.) or psychiatric illness.
• Seizures, brain surgery, organic brain disease and history of organic affective disorder and at the brain MRI, abnormalities other than brain atrophy.
• If you have a history of the test drug hypersensitivity
• If you are taking memantin (dementia)
• If you participated in another clinical trial within 3 months.
• If pregnant or fertile women, who have not received sterilization or if you do not want to use an effective method of contraception.
• In laboratory tests, if you have kidney failure or liver failure.
• If you have history or habitual drinking or a history of drug abuse.
• Uncontrolled diabetes or hypertension.
• If determined to be inappropriate for clinical trials.

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

MedicalExcellence

Seoul, Secho-gu Banpo-dong, 505, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease; Depressive Disorder

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Seol-Heui HAN, Professor

  Kunkuk Universicy Hospital

  PRINCIPAL INVESTIGATOR

• Dong-Won YANG, Professor

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

• Sung-Yoon KIM, Professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Kun-Woo PARK, Professor

  Korea University Hospital

  PRINCIPAL INVESTIGATOR

• Do-Hoon KIM, Professor

  Hanlym University Hospital

  PRINCIPAL INVESTIGATOR

• So-Young MUN, Professor

  AJU University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 26, 2013
• Study Start: November 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

KR (1)