Aβ Dynamics in LLMD

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05004987
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Escitalopram Oxalate — DRUG
    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.
  • Placebo — DRUG
    Daily dose of placebo will mimic that of ESC.

Study Details

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).

Key Dates

Start date
Feb 4, 2022
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Escitalopram (ESC)
  • Placebo Comparator: Placebo (PBO)

Primary Outcome Measure

Change in Cerebrospinal Fluid (CSF) Aβ40 Biomarker Levels [ Time Frame: Baseline, Week 8 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Nunzio Pomara, MD (PRINCIPAL_INVESTIGATOR)
Nathan S. Kline Institute for Psychiatric ResearchOrangeburgNew York10962
Antero Sarreal, MD
[email protected]
845-398-6532
Nunzio Pomara, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Alzheimer's diseaseDepression
By specialty
NeurologyDementia careBrain disordersGeriatricsPsychiatryMental healthBehavioral health
By research site
NYU Langone Health· New York, NYNathan S. Kline Institute for Psychiatric Research· Orangeburg, NY

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