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Selective Serotonin Reuptake Inhibitor
Escitalopram for Depression and Alzheimer's Prevention
Phase 4
Recruiting
Led By Nunzio Pomara, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Only individuals with normal hepatic and renal function including normal creatinine clearance will be included
Medically stable with no significant cerebrovascular, neurological, or systemic disease expected to interfere with the study
Must not have
Treatment with specific medications not permitted
Evidence of clinically relevant or unstable cardiac, pulmonary, endocrine or hematological conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will test if treating depression with the antidepressant escitalopram can affect biological markers related to Alzheimer's disease. It targets people with major depressive disorder to see if reducing their depression can also lower their risk of developing Alzheimer's. The study compares escitalopram to understand its effects on these markers. Escitalopram is commonly used to treat major depressive disorder.
Who is the study for?
This trial is for individuals aged 60+ with major depressive disorder and no cognitive impairment, as indicated by specific mental state and dementia rating scales. Participants must be medically stable, fluent in English, willing to undergo various tests including MRI and lumbar puncture, and not have a significant history of neurological disorders or substance abuse.
What is being tested?
The study compares the antidepressant escitalopram oxalate against a placebo to see if treating depression affects Alzheimer's disease biomarkers. It aims to understand whether improving depression can normalize biological factors linked to Alzheimer's risk.
What are the potential side effects?
Escitalopram may cause side effects like nausea, headache, trouble sleeping, fatigue, dry mouth, increased sweating, sexual problems and weight changes. Placebo has no active ingredients but some participants might report symptoms due to their expectations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver and kidney functions are normal.
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I don't have any major health issues that could affect my participation in the study.
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I am 60 years old or older.
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I can hear well and see clearly, with or without glasses.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently taking any medications that are excluded from the trial.
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I have no unstable heart, lung, hormone, or blood conditions.
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I do not have mental retardation or serious neurological disorders like Parkinson's.
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I use insulin to manage my diabetes.
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I have a history of brain issues, including tumors, damage, or significant trauma.
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I am currently taking fluoxetine.
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I have had a bad reaction or no improvement with escitalopram.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Escitalopram (ESC)Active Control1 Intervention
Group II: Placebo (PBO)Placebo Group1 Intervention
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby improving communication between nerve cells.
NMDA receptor antagonists help regulate glutamate activity, which can be harmful in excessive amounts, thus protecting neurons from damage. Additionally, SSRIs like Escitalopram, primarily used to treat depression, are being studied for their potential to normalize AD biomarkers and reduce peripheral inflammation, which may help mitigate some symptoms of AD.
These treatments are crucial as they aim to improve cognitive function, manage behavioral symptoms, and potentially slow disease progression, enhancing the quality of life for AD patients.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,400 Previous Clinical Trials
854,859 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,766 Previous Clinical Trials
28,184,750 Total Patients Enrolled
Nunzio Pomara, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Placebo (PBO)
- Group 2: Escitalopram (ESC)
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