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 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…
Conditions studied
Alzheimer Disease, Major Depressive Disorder
About this study
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: 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 outcomes
- Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker Levels (Baseline, Week 8)
- Change in Cerebrospinal Fluid (CSF) Aβ42 Biomarker Levels (Baseline, Week 8)
- Change in Vascular Dysfunction (VD) Biomarker Levels (Baseline, Week 8)
- Change in Scores on Montgomery-Asberg Depression Ration Scale (MADRS) (Baseline, Week 8)
Eligibility information
Study locations
- NYU Langone Health, New York, New York 10016 United States
- Nathan S. Kline Institute for Psychiatric Research, Orangeburg, New York 10962 United States
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.