Aβ Dynamics in LLMD

This study is looking at how depression might be linked to Alzheimer's disease (AD). Researchers want to see if treating depression can change certain biological markers related to AD. You might be able to join if you are 60 or older, have major depressive disorder, and meet other health criteria. The study will compare an FDA-approved antidepressant called escitalopram oxalate with a placebo (an inactive substance). Success would mean that reducing depressive symptoms leads to normal levels of AD markers in your cerebrospinal fluid (CSF) and other inflammatory markers. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. It compares escitalopram oxalate to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Biomarker levels will be measured at the beginning of the study and again at Week 8.

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NCT05004987

Aβ Dynamics in LLMD

Recruiting
PHASE4Ages 60+InterventionalTreatment
NYU Langone Health
~60 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Escitalopram OxalatePlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker Levels
Measured over Baseline, Week 8
+3 more outcomes measured
Alzheimer Disease
Major Depressive Disorder
2 sites across 1 states
New York2
  • Nunzio Pomara, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Inclusion

If study partner is not available, the CDR will be skipped.

Exclusion

For subjects taking prescribed psychoactive medications and supplements (i.e., opioids, amphetamines, amphetamine-like substances, and cannabinoids), must be on a stable dose for 1 month prior to randomization.
Anti-Parkinsonian medications (carbidopa/levodopa, amantadine, bromocriptine, pergolide, selegiline).
Cholinesterase inhibitors and memantine
Continuous aspirin (any dosage) use which can affect platelet function is prohibited. Exception: If participant is on low dose aspirin for prophylaxis and is willing to temporarily discontinue prior to research blood draw (i.e., 2 days before).
Continuous use of other medications which are also known to affect platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs), anti-histamines. Exception: If participant is taking medication continuously and is willing to temporarily discontinue prior to research blood draw (i.e., 2 days before)
  • Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker LevelsBaseline, Week 8
  • Change in Cerebrospinal Fluid (CSF) Aβ42 Biomarker LevelsBaseline, Week 8
  • Change in Vascular Dysfunction (VD) Biomarker LevelsBaseline, Week 8
  • Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS)Baseline, Week 8

    MADRS consists of 10 items evaluating core symptoms of depression (e.g, apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thought, and suicidal thoughts). Each symptom is rated on a 0-6 scale (0=no abnormality, 6=severe). The total score ranges from 0 to 60; the higher the score, the more severe the symptoms.