NCT05004987

Aβ Dynamics in LLMD

Depression Treatment and Aβ Dynamics: A Study of Alzheimer's Disease Risk (ABD Study)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Alzheimer Disease
• Major Depressive Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-04
• Primary completion: 2026-09-30
• Completion: 2027-01-29
• First posted: 2021-08-13
• Last updated: 2025-06-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study