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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: Active Phase 2 study of Cognitive Decline and Depressive Disorder, Treatment-Resistant, sponsored by Vanderbilt University Medical Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Wechsler Adult Intelligence Scale(WAIS-R) Digit Symbol Task score will be used to measure processing speed. A composite score is derived with two other test scores of WAIS-R Pattern Comparison Test Score by extracting latent fact and factor loadings, creating a purer measure of processing speed. Higher scores indicate better performance.

Conditions Studied

Cognitive Decline Depressive Disorder, Treatment-Resistant Gait Impairment Late Life Depression Levodopa

Interventions

  • DRUG Placebo
  • DRUG L-Dopa

Study Locations (2)

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Tennessee

  • Vanderbilt Psychiatric Hospital - Nashville

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2021-02-15
Est. Completion 2026-07-30
Phase Phase 2
Vanderbilt University Medical Center

677 total trials

What the registry record for NCT04469959 still lists

NCT04469959 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,148-participant average among 61 other Cognitive Decline trials with a reported enrollment target (91% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Cognitive Decline

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04469959's enrollment target sits among peer trials

100 41st of 61 higher than 19 of 61 other Cognitive Decline trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cognitive Decline trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04469959, the US trial registry maintained by the National Library of Medicine. NCT04469959 (mid enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.