NYU Langone Health
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).
Inclusion Criteria: 1. 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 d…
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.
Daily dose of placebo will mimic that of ESC.
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