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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 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.
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-02-04 |
| Est. Completion | 2027-01-29 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05004987
The ClinicalTrials.gov registry entry for NCT05004987 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (98% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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