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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8
Awards & highlights

Study Summary

This trial will examine if treating depression can help prevent Alzheimer's disease by looking at changes in biomarkers.

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.Check my eligibility
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.See study design
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 below
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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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker Levels
Change in Cerebrospinal Fluid (CSF) Aβ42 Biomarker Levels
Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS)
+1 more
Other outcome measures
Change in Cerebrospinal Fluid (CSF) P-tau Biomarker Levels
Change in Cerebrospinal Fluid (CSF) T-tau Biomarker Levels
Change in Plasma Aβ Biomarker Levels

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Escitalopram (ESC)Active Control1 Intervention
Group II: Placebo (PBO)Placebo Group1 Intervention

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,371 Previous Clinical Trials
841,314 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,682 Previous Clinical Trials
28,026,024 Total Patients Enrolled
Nunzio Pomara, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

Alzheimer's Disease Research Study Groups: Placebo (PBO), Escitalopram (ESC)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate enrolment rate for this clinical experiment?

"Affirmative. Details on clinicaltrials.gov demonstrate that this medical trial is actively looking for participants, having been first posted on February 4th 2022 and last updated a few days ago. The study requires the recruitment of 90 patients from two different sites."

Answered by AI

Have there been earlier examinations of Escitalopram (ESC)?

"Presently, there are 23 clinical trials underway investigating Escitalopram (ESC). Of those active studies, 5 have entered their final Phase 3. Despite the majority of these ESC-related investigations being based in Cincinnati, Ohio, a total of 45 locations across the USA are running related experiments."

Answered by AI

Has the United States Food and Drug Administration authorized Escitalopram (ESC)?

"ESC's safety is rated highly by Power, as it has been deemed suitable for Phase 4 clinical trials due to its approval status. The rating of 3 out of a possible three speaks to the trustworthiness and reliability of this medication."

Answered by AI

Are there still vacant slots for participants within this experiment?

"Clinicaltrials.gov confirms that this medical trial is open to patient recruitment, with the first posting on February 4th 2022 and last update being on the 8th of February."

Answered by AI

Who else is applying?

What state do they live in?
California
Washington
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
NYU Langone Health
Nathan S. Kline Institute for Psychiatric Research

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Aβ Dynamics in LLMD
2022. "Aβ Dynamics in LLMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05004987.
All > Alzheimer Disease > Alzheimers Disease
~40 spots leftby Apr 2026
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