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

Last updated: August 19, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Trial Not Available

Phase

2

Condition

Mild Cognitive Impairment

Memory Problems

Mental Disability

Treatment

Physical, Occupational, Speech Therapy

Medications for symptoms management

Provider Counseling

Clinical Study ID

NCT06234462
STU-2023-0234
  • Ages 20-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 20-65

  • Can provide informed consent

  • Confirmed COVID+ test (either rapid antigen or PCR) between 8 weeks and one yearprior to initial visit.

  • Able to consent in English

  • Endorse symptoms during their initial evaluation and history with the provider thatbegan around the time of the acute COVID19 infection (subjective) includingcognitive changes such as cognitive fatigue, brain fog, memory issues,attentionissues AND have symptoms in at least 1 out of the 2 following symptom categories:

  • Category 1: Decreased endurance, physical fatigue, weakness

  • Category 2: Depression, anxiety

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to amantadine

  • Clinically significant psychiatric, neurologic, renal, hepatic, opthalmologic,cardiac impairment in the opinion of the investigators, including but not limitedto:

  • Psychiatric:

  • Acute or chronic unstable Axis I psychiatric illness

  • History of psychosis

  • Severe depression Patient Health Questionnaire-9 (PHQ-9) score >= 20

  • Suicidality

  • Neurologic:

  • Epilepsy

  • Cognitive dysfunction predating COVID infection

  • History of delirium

  • Neurologic conditions with agitation or confusion

Study Design

Treatment Group(s): 4
Primary Treatment: Physical, Occupational, Speech Therapy
Phase: 2
Study Start date:
June 01, 2025
Estimated Completion Date:
October 01, 2025

Study Description

This study is a prospective, open-label, single-blind, randomized control study. Study duration is approximately 6 weeks starting at the baseline visit. We will recruit 30 participants (15 per arm) for this pilot study.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • UT Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Site Not Available

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