Amantadine Therapy for Cognitive Impairment in Long COVID

Launched by OHIO STATE UNIVERSITY · Sep 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called amantadine may help improve thinking and memory problems in people dealing with Long COVID, a condition that affects some individuals after they have recovered from COVID-19. The researchers want to see if amantadine can help with cognitive issues and if certain lab tests can predict who might benefit the most from this treatment. The trial is currently looking for participants aged 18 and older who have experienced cognitive difficulties related to Long COVID within the past year.

To participate, individuals must have a confirmed COVID-19 diagnosis and show signs of cognitive impairment, which will be evaluated using specific questionnaires. Participants will need to attend study visits and follow certain guidelines, such as avoiding alcohol during the trial. It’s important to note that people with certain medical histories or conditions may not be eligible, so interested individuals should discuss their situation with the study team. Overall, this study aims to help find effective treatments for cognitive challenges faced by those recovering from COVID-19.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• 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.