WITHDRAWN

A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid

Talk to us

Conditions

Long COVIDPost-Acute COVID-19 Syndrome

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or "long-hauler" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.

Official Title

Feasibility Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid: A Pilot Randomized Control Trial

Quick Facts

Study Start:2025-06
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT06234462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:20 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 20-65
  2. * Can provide informed consent
  3. * Confirmed COVID+ test (either rapid antigen or PCR) between 8 weeks and one year prior to initial visit.
  4. * Able to consent in English
  5. * Endorse symptoms during their initial evaluation and history with the provider that began around the time of the acute COVID19 infection (subjective) including cognitive changes such as cognitive fatigue, brain fog, memory issues,attention issues AND have symptoms in at least 1 out of the 2 following symptom categories:
  6. * Category 1: Decreased endurance, physical fatigue, weakness
  7. * Category 2: Depression, anxiety
  1. * Known hypersensitivity to amantadine
  2. * Clinically significant psychiatric, neurologic, renal, hepatic, opthalmologic, cardiac impairment in the opinion of the investigators, including but not limited to:
  3. * Psychiatric:
  4. * Acute or chronic unstable Axis I psychiatric illness
  5. * History of psychosis
  6. * Severe depression Patient Health Questionnaire-9 (PHQ-9) score \>= 20
  7. * Suicidality
  8. * Neurologic:
  9. * Epilepsy
  10. * Cognitive dysfunction predating COVID infection
  11. * History of delirium
  12. * Neurologic conditions with agitation or confusion

Contacts and Locations

Principal Investigator

Amy Mathews, M.D.
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Amy Mathews, M.D., PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2025-06
Study Completion Date2025-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Long COVID
  • Post-Acute COVID-19 Syndrome