Depression treatment and A dynamics: A study of Alzheimer s disease risk (ABD Study)

Brief description of study

The study will use a randomized 8-week double-blind placebo controlled parallel trial using escitalopram to test the associations between depressive symptoms (captured by the MADRS and other depression scales), and AD biomarkers in both CSF and plasma as well as changes in vascular dysfunction (VD)-associated biomarkers(MMP2, MMP9, homocysteine, and platelet activation markers P-selectin and GP IIa/IIIb). The primary endpoints are the severity of depression symptoms at baseline, the change in depression scores after treatment with escitalopram, and the associated changes in AD and VD markers peptide levels. Secondary endpoints are depression severity at baseline, which will be tested in regression models in relation to the AD biomarkers (Aß peptides in CSF) cross-sectionally at baseline and after antidepressant treatment to test that Aß peptides are correlated with symptoms. The study will also examine if decreased levels of VD-associated biomarkers will (at least partially) mediate the effect of depression treatment response on increases in CSF Aß levels. This proposal will be the first to explore the relationships between CSF AD and VD biomarker levels and MDD symptom severity in cognitively normal MDD patients and the direction of causation between changes in Aß and VD biomarkers and changes in MDD symptom severity. The results of this study, if successful, may provide a rationale for reducing AD risk through a more effective treatment of depression in the elderly.


Clinical Study Identifier: s21-00535
ClinicalTrials.gov Identifier: NCT05004987
Principal Investigator: Nunzio Pomara.
Other Investigators: Timothy Michael Shepherd, Jaime Ramos Cejudo, Henry Rusinek, Evan G Stein, Michele Santacatterina, Ricardo Miguel Osorio Suarez, Kathy F Yates, Dan Iosifescu.


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