- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06055244
Amantadine Therapy for Cognitive Impairment in Long COVID (AmantadineLC)
March 5, 2024 updated by: Andrew Schamess, Ohio State University
Amantadine Therapy for Cognitive Impairment Related to Post-COVID Condition
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrew I Schamess, MD
- Phone Number: (614) 688-6470
- Email: andrew.schamess@osumc.edu
Study Contact Backup
- Name: Seuli Brill, MD
- Phone Number: (614) 293-8054.
- Email: seuli.brill@osumc.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43221
- Recruiting
- The Ohio State University Medical Center
-
Contact:
- Tait Palm, B.S.
- Phone Number: 614-293-8054
- Email: 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
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
- 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.
Exclusion Criteria:
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.
- 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.
- Prior diagnosis of dementia, neurodegenerative disorder, multiple sclerosis or other autoimmune neurologic disorder, or cognitive impairment.
- Enrolled in any other research study involving intervention for PASC.
- If the individual is of child-bearing potential, is not consistently using one or more forms of prescribed birth control.
- Is not willing to abstain from alcohol for the duration of the study.
- Is not willing and able to adhere to study visits and study-related procedures/assessments.
- Is not able to provide informed consent to participate in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amantadine
Subjects will be treated with amantadine.
|
Subjects will be give amantadine 100 mg twice daily.
|
Placebo Comparator: Placebo
Subjected received placebo identical to amantadine in appearance.
|
Subjects will be give amantadine 100 mg twice daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in cognitive symptoms
Time Frame: 4 months
|
Improvement in scores on self-assessment of overall cognitive functioning
|
4 months
|
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
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood symptoms
Time Frame: 4 months
|
Subjects will be administered anxiety and depression questionnaires to determine if there is improvement in mood symptoms.
|
4 months
|
Medication tolerability
Time Frame: 4 months
|
Subjects will complete a questionnaire addressing tolerability of amantadine and side effects experienced
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
December 7, 2023
Primary Completion (Estimated)
April 15, 2025
Study Completion (Estimated)
May 15, 2025
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 22, 2023
First Posted (Actual)
September 26, 2023
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neurocognitive Disorders
- Disease Attributes
- Cognition Disorders
- Chronic Disease
- Post-Infectious Disorders
- COVID-19
- Disease
- Cognitive Dysfunction
- Post-Acute COVID-19 Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Dopamine Agents
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Amantadine
Other Study ID Numbers
- 2023H0268
- GF317855 (Other Grant/Funding Number: Private Donor)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
It is not yet known if there will be a plan to make IPD available.
IPD Sharing Time Frame
Upon study completion
IPD Sharing Access Criteria
As appropriate
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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