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NCT04943393 · ClinicalTrials.gov registry record

Remote Neurocognitive and Psychological Assessment in PKU

A clinical trial of Phenylketonurias, sponsored by University of Missouri-Columbia.

Completed
Registry status
84
Enrollment target
2
Study locations

NCT04943393: Completed study of Phenylketonurias, sponsored by University of Missouri-Columbia.

NCT04943393 is a study of Phenylketonurias that has completed, run by University of Missouri-Columbia. The registered enrollment target is 84 participants, above the 29-participant average among 5 other Phenylketonurias trials with a reported enrollment target (190% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04943393, a study of Phenylketonurias, has completed, sponsored by University of Missouri-Columbia.

COMPLETED
Registry status
84 participants
Enrollment target
2
Study locations

Study Summary

PKU is a rare autosomal recessive condition associated with disruption in dopamine synthesis. Although early diagnosis and treatment prevent the severe impairments associated with untreated PKU, individuals with early-treated PKU (ETPKU) nonetheless experience significant sequelae, including impaired working memory and increased risk for anxiety problems. Past research with other clinical populations (e.g., generalized anxiety disorder) suggests that the two phenomena may be linked, with increased anxiety contributing to poorer WM performance. Currently we propose to initiate an exciting new line of research examining the potential relationship between anxiety and WM in ETPKU. The proposed study will also apply remote neuropsychological performance-based assessment to the study of ETPKU and thus overcoming the geographical limitations/challenges associated with recruitment of participants with this rare disease.

Primary Outcome

Composite score based on multiple working memory-related CANTAB tests

Conditions Studied

Interventions

  • OTHER nointervention

Study Locations (2)

Georgia

  • Emory University - Atlanta

Missouri

  • University of Missouri - Columbia

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2020-11-24
Est. Completion 2021-10-02
University of Missouri-Columbia

291 total trials

What the finished NCT04943393 record still lists

NCT04943393 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 84 participants, a relatively small participant target, above the 29-participant average among 5 other Phenylketonurias trials with a reported enrollment target (190% higher).

The record links to 1 condition, with Phenylketonurias appearing as the primary indexed condition, and to 1 intervention - of which nointervention is the first listed.

NCT04943393 reports a single indexed study location in Georgia, Missouri.

Frequently Asked Questions

What is clinical trial NCT04943393 about?

NCT04943393 is a clinical study titled "Remote Neurocognitive and Psychological Assessment in PKU". PKU is a rare autosomal recessive condition associated with disruption in dopamine synthesis. Although early diagnosis and treatment prevent the severe impairments associated with untreated PKU, individuals with early-treated PKU (ETPKU) nonetheless experience significant sequelae, including impaire...

What is the current status of trial NCT04943393?

This trial is currently completed. The enrollment target is 84 participants. The study started on 2020-11-24. Estimated completion is 2021-10-02.

What conditions does trial NCT04943393 study?

This clinical trial studies the following conditions: Phenylketonurias.

What interventions are being tested in trial NCT04943393?

The interventions under investigation include: nointervention (OTHER).

Who is sponsoring clinical trial NCT04943393?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04943393 being conducted?

This trial has 2 study locations across Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04943393, the US trial registry maintained by the National Library of Medicine. NCT04943393 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.