Amantadine Therapy for Cognitive Impairment in Long COVID (NCT06055244) | Clinical Trial Compass
CompletedPhase 2
Amantadine Therapy for Cognitive Impairment in Long COVID
United States64 participantsStarted 2023-12-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age and above at the signing of informed consent
✓. 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.
✓. Subjective Cognitive impairment associated with PASC
✓. 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.
✓. Is willing and able to comply with study visits and study-related procedures/assessments.
✓. Is able to provide informed consent to participate in the study 5.
✓. Is not currently taking a medication with adverse interactions with amantadine. (Table 2)
✓. If the participant is of child bearing potential, , is not pregnant at enrollment based on negative urine pregnancy test.
Exclusion criteria
✕. At risk for complications of study drug with conditions such as:
✕. Is taking a medication that adversely interacts with amantadine (see Table 2)
✕. 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.