NCT05004987 · NYU Langone Health
Aβ Dynamics in LLMD
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Escitalopram Oxalate
The daily dose of ESC/PBO will be 10 mg for the first 2 weeks, then increase to 20 mg as tolerated, with an option to reduce back to 10 mg if necessary.
DRUG
Placebo
Daily dose of placebo will mimic that of ESC.
Primary outcome measures
Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker Levels
Time frame: Baseline, Week 8
Change in Cerebrospinal Fluid (CSF) Aβ42 Biomarker Levels
Time frame: Baseline, Week 8
Change in Vascular Dysfunction (VD) Biomarker Levels
Time frame: Baseline, Week 8
Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male and female subjects, age 60+ years inclusive, at the time of signing the informed consent. 2. Meeting Structured Clinical Interview (SCID-5-RV) for DSM-5 criteria for Major depressive disorder. 3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥18. 4. Have results of a physical examination, neurological examination, vitals, and EKG within normal limits at screening. 5. Cognitively unimpaired at screening visit as defined by Mini-Mental State Examination (MMSE) \>27. 6. Clinical Dementia Rating Scale (CDR) Global of 0\*. 7. A score of 85 or greater on the RBANS delayed memory index score. 8. Fluent in English, because some of the instruments used in this study have not been translated and validated in other languages, and are able to read at a 6th grade level or equivalent, as determined by the PI. 9. Medically stable with no significant cerebrovascular, neurological, or systemic disease expected to interfere with the study. 10. Adequate auditory acuity a
Where
- New York, New York
- Orangeburg, New York
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations