RECRUITING

Amantadine Therapy for Cognitive Impairment in Long COVID

Conditions

Long COVID Post-COVID19 Condition Post-Acute COVID19 Syndrome PASC post COVID condition cognition brain fog amantadine

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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

This study will look at the effects of amantadine on cognitive function in persons with Long COVID. It will also collect specimens to study possible causes of cognitive symptoms in Long COVID, and whether any lab tests can predict who will respond better to amantadine.

Official Title

Amantadine Therapy for Cognitive Impairment Related to Post-COVID Condition

Quick Facts

Study Start:2023-12-07

Study Completion:2025-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06055244

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 18 years of age and above at the signing of informed consent 2. Had a positive laboratory or home test for COVID19 within one year prior to signing of informed consent, with subsequent symptoms meeting criteria for PASC. 3. Subjective Cognitive impairment associated with PASC 4. Cognitive symptoms will be formally assessed at a pre-enrollment visit using the PROMIS Cognitive Function Questionnaire (CGQ) and the PROMIS Cognitive Abilities subset (CAS), which are validated patient-reported measures of subjective cognitive functioning. Potential participants must have a cumulative score less than 60 (indicating at least mild subjective cognitive dysfunction) to be eligible. 5. Is willing and able to comply with study visits and study-related procedures/assessments. 6. Is able to provide informed consent to participate in the study 5. 7. Is not currently taking a medication with adverse interactions with amantadine. (Table 2) 8. If the participant is of child bearing potential, , is not pregnant at enrollment based on negative urine pregnancy test. 9. If the participant is of child-bearing potential, is consistently using one or more forms of prescribed birth control, such as an oral contraceptive, intrauterine device or a long-acting reversible contraceptive. 10. Is not breastfeeding. 11. Is willing to abstain from alcohol use for the duration of the study. 12. Endorses self-reported cognitive impairment on the PROMIS CF\[40\]. 13. Does not have any other contraindications to amantadine use as noted in section 6 below or as identified by the study clinician investigators.	1. At risk for complications of study drug with conditions such as: * Lifetime history of compulsive or impulsive behavior: Compulsive gambling, hypersexuality, binge eating; suicidality. * Underweight, malnourished at time of enrollment. * History of restrictive eating disorder within 3 months prior to consent. * Lifetime history of heart failure or diagnosed cardiac arrhythmia. * Untreated angle closure glaucoma at time of enrollment. * Lifetime history of psychosis or psychotic disorder. * Lifetime history of seizure disorder. * Known allergy to amantadine. * History of binge drinking, heavy alcohol use, or alcohol use disorder as defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)\[54\] and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\[55\]. * Use of kava-kava within 3 months prior to consent. * Breastfeeding at screening or expected to be breastfeeding during study period. * Pregnant at time of screening or expecting to become pregnant during the study period. 2. Is taking a medication that adversely interacts with amantadine (see Table 2) 3. Has any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study. 4. Prior diagnosis of dementia, neurodegenerative disorder, multiple sclerosis or other autoimmune neurologic disorder, or cognitive impairment. 5. Enrolled in any other research study involving intervention for PASC. 6. If the individual is of child-bearing potential, is not consistently using one or more forms of prescribed birth control. 7. Is not willing to abstain from alcohol for the duration of the study. 8. Is not willing and able to adhere to study visits and study-related procedures/assessments. 9. Is not able to provide informed consent to participate in the study.

Inclusion Criteria

Exclusion Criteria

1. 18 years of age and above at the signing of informed consent
2. Had a positive laboratory or home test for COVID19 within one year prior to signing of informed consent, with subsequent symptoms meeting criteria for PASC.
3. Subjective Cognitive impairment associated with PASC
4. Cognitive symptoms will be formally assessed at a pre-enrollment visit using the PROMIS Cognitive Function Questionnaire (CGQ) and the PROMIS Cognitive Abilities subset (CAS), which are validated patient-reported measures of subjective cognitive functioning. Potential participants must have a cumulative score less than 60 (indicating at least mild subjective cognitive dysfunction) to be eligible.
5. Is willing and able to comply with study visits and study-related procedures/assessments.
6. Is able to provide informed consent to participate in the study 5.
7. Is not currently taking a medication with adverse interactions with amantadine. (Table 2)
8. If the participant is of child bearing potential, , is not pregnant at enrollment based on negative urine pregnancy test.
9. If the participant is of child-bearing potential, is consistently using one or more forms of prescribed birth control, such as an oral contraceptive, intrauterine device or a long-acting reversible contraceptive.
10. Is not breastfeeding.
11. Is willing to abstain from alcohol use for the duration of the study.
12. Endorses self-reported cognitive impairment on the PROMIS CF\[40\].
13. Does not have any other contraindications to amantadine use as noted in section 6 below or as identified by the study clinician investigators.

1. At risk for complications of study drug with conditions such as:
* Lifetime history of compulsive or impulsive behavior: Compulsive gambling, hypersexuality, binge eating; suicidality.
* Underweight, malnourished at time of enrollment.
* History of restrictive eating disorder within 3 months prior to consent.
* Lifetime history of heart failure or diagnosed cardiac arrhythmia.
* Untreated angle closure glaucoma at time of enrollment.
* Lifetime history of psychosis or psychotic disorder.
* Lifetime history of seizure disorder.
* Known allergy to amantadine.
* History of binge drinking, heavy alcohol use, or alcohol use disorder as defined by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)\[54\] and the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\[55\].
* Use of kava-kava within 3 months prior to consent.
* Breastfeeding at screening or expected to be breastfeeding during study period.
* Pregnant at time of screening or expecting to become pregnant during the study period.
2. Is taking a medication that adversely interacts with amantadine (see Table 2)
3. Has any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study.
4. Prior diagnosis of dementia, neurodegenerative disorder, multiple sclerosis or other autoimmune neurologic disorder, or cognitive impairment.
5. Enrolled in any other research study involving intervention for PASC.
6. If the individual is of child-bearing potential, is not consistently using one or more forms of prescribed birth control.
7. Is not willing to abstain from alcohol for the duration of the study.
8. Is not willing and able to adhere to study visits and study-related procedures/assessments.
9. Is not able to provide informed consent to participate in the study.

Contacts and Locations

Study Contact

Andrew I Schamess, MD

CONTACT

(614) 688-6470

andrew.schamess@osumc.edu

Seuli Brill, MD

CONTACT

(614) 293-8054.

seuli.brill@osumc.edu

Study Locations (Sites)

The Ohio State University Medical Center

Columbus, Ohio, 43221

United States

Collaborators and Investigators

Sponsor: Ohio State University

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 Date2023-12-07

Study Completion Date2025-05-15

Study Record Updates

Study Start Date2023-12-07

Study Completion Date2025-05-15

Terms related to this study

Keywords Provided by Researchers

long covid
PASC
post COVID condition
cognition
brain fog
amantadine

Additional Relevant MeSH Terms

Long COVID
Post-COVID19 Condition
Post-Acute COVID19 Syndrome