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Amantadine Therapy for Cognitive Impairment in Long COVID (AmantadineLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06055244
Recruitment Status : Not yet recruiting
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Andrew Schamess, Ohio State University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Long COVID Post-COVID19 Condition Post-Acute COVID19 Syndrome Drug: Amantadine Phase 1

Detailed Description:
This study will enroll 60 subjects with Long COVID and cognitive symptoms such as problems with memory, concentration, speech and attention, and "brain fog." Subjects will be assigned randomly to two groups. One group will be treated with amantadine, the other group will receive placebo. The study will last 4 months. During that time, subjects will be assessed at regular intervals with symptom questionnaires, cognitive tests, and lab measurements.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot randomized clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amantadine Therapy for Cognitive Impairment Related to Post-COVID Condition
Estimated Study Start Date : October 15, 2023
Estimated Primary Completion Date : April 15, 2025
Estimated Study Completion Date : May 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Amantadine
Subjects will be treated with amantadine.
 Drug: Amantadine
Subjects will be give amantadine 100 mg twice daily.
Placebo Comparator: Placebo
Subjected received placebo identical to amantadine in appearance.
 Drug: Amantadine
Subjects will be give amantadine 100 mg twice daily.


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in cognitive symptoms [ Time Frame: 4 months ]
    Improvement in scores on self-assessment of overall cognitive functioning

  2. Improvement on objective cognitive testing [ Time Frame: 4 months ]
    Subjects will be administered battery of cognitive tests to determine if there is a change in objective cognitive function


Secondary Outcome Measures :
  1. Mood symptoms [ Time Frame: 4 months ]
    Subjects will be administered anxiety and depression questionnaires to determine if there is improvement in mood symptoms.

  2. Medication tolerability [ Time Frame: 4 months ]
    Subjects will complete a questionnaire addressing tolerability of amantadine and side effects experienced


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055244


Contacts
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Contact: Andrew I Schamess, MD (614) 688-6470 andrew.schamess@osumc.edu
Contact: Seuli Brill, MD (614) 293-8054. seuli.brill@osumc.edu

Locations
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United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43221
Contact: Tait Palm, B.S.    614-293-8054    tait.palm@osumc.edu   
Principal Investigator: Andrew I Schamess, MD         
Principal Investigator: Seuli Brill, MD         
Sub-Investigator: Bowman-Burpee Susan, RN         
Sub-Investigator: Oltz Eugene, Ph.D.         
Sub-Investigator: Gumina Richard, MD         
Sub-Investigator: Shan-Lu Liu, PhD         
Sponsors and Collaborators
Ohio State University
More Information
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Responsible Party: Andrew Schamess, Associate Professor - Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT06055244    
Other Study ID Numbers: 2023H0268
GF317855 ( Other Grant/Funding Number: Private Donor )
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Andrew Schamess, Ohio State University:
long covid
PASC
post COVID condition
 cognition
brain fog
amantadine
Additional relevant MeSH terms:
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COVID-19
Post-Acute COVID-19 Syndrome
Disease
Cognitive Dysfunction
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
 Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Post-Infectious Disorders
Chronic Disease
Disease Attributes
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action