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NCT04469959 · ClinicalTrials.gov registry record · Phase 2
Dopaminergic Dysfunction in Late-Life Depression
A Phase 2 study of Cognitive Decline and Depressive Disorder, Treatment-Resistant, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT04469959 is a Phase 2 study of Cognitive Decline and Depressive Disorder, Treatment-Resistant that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 100 participants, below the 1,148-participant average among 61 other Cognitive Decline trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04469959, a Phase 2 study of Cognitive Decline and Depressive Disorder, Treatment-Resistant, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study Summary
Late-Life Depression (LLD), or depression in older adults, often presents with motivational deficits, deficits in performance in cognitive domains including processing speed and executive dysfunction, and mobility impairments. This triad of findings implicate dopaminergic dysfunction as a core pathophysiologic feature in depression, and may contribute to cognitive decline and motor disability. Normal aging results in brain-wide dopamine declines, decreased D1/D2 receptor density, and loss of dopamine transporters. Although brain changes associated with depression and aging converge on dopamine circuits, the specific disturbances in LLD and how responsive the system is to modulation remain unclear. In this study, investigators are testing integrative model that aging, in concert with pro-inflammatory shifts, decreases dopamine signaling. These signally changes affects behaviors supported by these circuits, in the context of age-associated cortical atrophy and ischemic microvascular changes, resulting in variable LLD phenotypes. Investigators propose a primary pathway where dopaminergic dysfunction in depressed elders contributes to slowed processing speed and mobility impairments that increase the effort cost associated with voluntary behavior. The central hypothesis of this study is that late-life depression is characterized by dysfunction in the dopamine system and, by enhancing dopamine functioning in the brain. By improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG L-Dopa
Study Locations (2)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Tennessee
- Vanderbilt Psychiatric Hospital - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-02-15 |
| Est. Completion | 2026-07-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04469959
The ClinicalTrials.gov registry entry for NCT04469959 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,148-participant average among 61 other Cognitive Decline trials with a reported enrollment target (91% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Cognitive Decline appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04469959 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Pennsylvania, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04469959 about?
NCT04469959 is a clinical study titled "Dopaminergic Dysfunction in Late-Life Depression". Late-Life Depression (LLD), or depression in older adults, often presents with motivational deficits, deficits in performance in cognitive domains including processing speed and executive dysfunction, and mobility impairments. This triad of findings implicate dopaminergic dysfunction as a core patho...
What is the current status of trial NCT04469959?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2021-02-15. Estimated completion is 2026-07-30.
What conditions does trial NCT04469959 study?
This clinical trial studies the following conditions: Cognitive Decline, Depressive Disorder, Treatment-Resistant, Gait Impairment, Late Life Depression, Levodopa.
What interventions are being tested in trial NCT04469959?
The interventions under investigation include: Placebo (DRUG), L-Dopa (DRUG).
Who is sponsoring clinical trial NCT04469959?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04469959 being conducted?
This trial has 2 study locations across Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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