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NCT05004987 · ClinicalTrials.gov registry record · Phase 4

Aβ Dynamics in LLMD

A Phase 4 study of Alzheimer Disease and Major Depressive Disorder, sponsored by NYU Langone Health.

Recruiting
Registry status
Phase 4
Development phase
60
Enrollment target
2
Study locations

NCT05004987: Recruiting Phase 4 study of Alzheimer Disease and Major Depressive Disorder, sponsored by NYU Langone Health.

NCT05004987 is a Phase 4 study of Alzheimer Disease and Major Depressive Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 60 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05004987, a Phase 4 study of Alzheimer Disease and Major Depressive Disorder, is actively recruiting participants, sponsored by NYU Langone Health.

RECRUITING
Registry status
Phase 4
Development phase
60 participants
Enrollment target
2
Study locations

Study Summary

This study will examine the biological factors that may modulate the relationship between depression and the development of Alzheimer's disease (AD). Since the direction of causation between depression and the biological factors associated with AD is unknown, the only way to understand cause and associated risk is to treat the depressive symptoms and examine the effects on AD biomarkers. The study involves an FDA-approved treatment for major depressive disorder. It will compare the SSRI antidepressant escitalopram with placebo. The hypothesis is that a reduction in depressive symptoms will be associated with a normalization of CSF AD biomarkers as well as peripheral inflammatory markers. This research would contribute to fundamental knowledge about potentially modifiable risks of Alzheimer's disease (AD).

Interventions

  • DRUG Placebo
  • DRUG Escitalopram Oxalate

Study Locations (2)

New York

  • NYU Langone Health - New York
  • Nathan S. Kline Institute for Psychiatric Research - Orangeburg

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-02-04
Est. Completion 2027-01-29
Phase Phase 4
NYU Langone Health

1,164 total trials

What NCT05004987 shows while recruiting

NCT05004987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05004987 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT05004987 about?

NCT05004987 is a clinical study titled "Aβ Dynamics in LLMD". This study will examine the biological factors that may modulate the relationship between depression and the development of Alzheimer's disease (AD). Since the direction of causation between depression and the biological factors associated with AD is unknown, the only way to understand cause and ass...

What is the current status of trial NCT05004987?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2022-02-04. Estimated completion is 2027-01-29.

What conditions does trial NCT05004987 study?

This clinical trial studies the following conditions: Alzheimer Disease, Major Depressive Disorder.

What interventions are being tested in trial NCT05004987?

The interventions under investigation include: Placebo (DRUG), Escitalopram Oxalate (DRUG).

Who is sponsoring clinical trial NCT05004987?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05004987 being conducted?

This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Alzheimer Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05004987's enrollment target sits among peer trials

60 187th of 306 higher than 108 of 306 other Alzheimer Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05004987, the US trial registry maintained by the National Library of Medicine. NCT05004987 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.