Amantadine Therapy for Cognitive Impairment Related to Post-COVID Condition

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

⁃ Is not breastfeeding.

⁃ Is willing to abstain from alcohol use for the duration of the study.

⁃ Endorses self-reported cognitive impairment on the PROMIS CF\[40\].

⁃ Does not have any other contraindications to amantadine use as noted in section 6 below or as identified by the study clinician investigators.

Locations
United States
Ohio
The Ohio State University Medical Center
RECRUITING
Columbus
Contact Information
Primary
Andrew I Schamess, MD
andrew.schamess@osumc.edu
(614) 688-6470
Backup
Seuli Brill, MD
seuli.brill@osumc.edu
(614) 293-8054.
Time Frame
Start Date: 2023-12-07
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Amantadine
Subjects will be treated with amantadine.
Placebo_comparator: Placebo
Subjected received placebo identical to amantadine in appearance.
Related Therapeutic Areas
Sponsors
Leads: Ohio State University

This content was sourced from clinicaltrials.gov