Amantadine for Cognitive Impairment in Post-COVID Syndrome
(AmantadineLC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Ohio State University
Must not be taking: Kava-kava, others
Disqualifiers: Psychosis, Seizure disorder, Heart failure, others
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This trial will test if amantadine can improve thinking and memory problems in people with Long COVID. It will involve 60 participants who have cognitive symptoms. The study will last several months, comparing amantadine to another treatment. Amantadine has been shown to enhance cognitive function in patients with traumatic brain injury and is well tolerated.
Will I have to stop taking my current medications?
You may need to stop taking certain medications if they have adverse interactions with amantadine. The study requires that you are not currently taking any medication that interacts negatively with amantadine.
What data supports the effectiveness of the drug amantadine for cognitive impairment in post-COVID syndrome?
Amantadine has shown potential benefits in improving mental status in Alzheimer's patients and has been effective in treating fatigue in multiple sclerosis, which are conditions with cognitive challenges. Additionally, it has antiviral properties that may help prevent COVID-19 progression, suggesting it could be beneficial for cognitive issues related to post-COVID syndrome.
12345Is amantadine generally safe for humans?
Amantadine, under various brand names like Gocovri and Osmolex ER, has been used safely in humans for conditions like Parkinson's disease and multiple sclerosis. It has been studied for its safety in treating symptoms related to these conditions, and ongoing research is assessing its safety for COVID-19-related symptoms.
16789How is the drug amantadine unique for treating cognitive impairment in post-COVID syndrome?
Amantadine is unique because it has antiviral, anti-inflammatory, and dopaminergic effects, which may help with cognitive impairment by enhancing dopamine release and potentially reducing neurological complications. Unlike other treatments, it has shown benefits in neurodegenerative diseases and may prevent COVID-19 progression, making it a novel option for post-COVID cognitive issues.
123510Eligibility Criteria
This trial is for adults over 18 who've had COVID-19 and are now experiencing cognitive issues due to Long COVID. They must not be pregnant, breastfeeding, or at risk of pregnancy without birth control. Participants should not have a history of seizures, heart problems, certain mental health conditions, or be on conflicting medications.Inclusion Criteria
Is willing to abstain from alcohol use for the duration of the study
Is not breastfeeding
If the participant is of child bearing potential, is not pregnant at enrollment based on negative urine pregnancy test
+10 more
Exclusion Criteria
You have a history of regularly drinking large amounts of alcohol or have been diagnosed with a serious alcohol problem.
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
+17 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomly assigned to receive either amantadine or placebo for cognitive impairment related to Long COVID
16 weeks
Regular intervals for assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests whether amantadine can improve brain function in people with Long COVID. It involves taking the drug and undergoing cognitive assessments while avoiding alcohol use during the study period.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AmantadineExperimental Treatment1 Intervention
Subjects will be treated with amantadine.
Group II: PlaceboPlacebo Group1 Intervention
Subjected received placebo identical to amantadine in appearance.
Amantadine is already approved in United States, United States, United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Symmetrel for:
- Parkinson's disease
- Extrapyramidal reactions
- Influenza A virus infections
🇺🇸 Approved in United States as Gocovri for:
- Dyskinesia in patients with Parkinson's disease
🇺🇸 Approved in United States as Osmolex ER for:
- Parkinson's disease
- Drug-induced extrapyramidal reactions
🇨🇦 Approved in Canada as Symmetrel for:
- Parkinson's disease
- Extrapyramidal reactions
- Influenza A virus infections
🇪🇺 Approved in European Union as Symmetrel for:
- Parkinson's disease
- Extrapyramidal reactions
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State University Medical CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
References
The use of amantadine in the prevention of progression and treatment of COVID-19 symptoms in patients infected with the SARS-CoV-2 virus (COV-PREVENT): Study rationale and design. [2022]COVID-19, a disease caused by infection with the SARS-CoV-2 virus, is asymptomatic or mildly symptomatic in most cases. Some patients, usually burdened with risk factors develop acute respiratory failure and other organ dysfunction. In such cases, the mortality rate is very high despite the use of intensive therapy. Amantadine has complex activity including antiviral, antiinflammatory and dopaminergic effects. This clinical trial will assess the efficacy and safety of amantadine in the prevention of COVID-19 progression toward acute respiratory failure and neurological complications.
Amantadine and the end-stage dementia of Alzheimer's type. [2019]Significant improvement of mental status was noted with amantadine therapy in three patients in whom autopsy subsequently showed Alzheimer's disease. Two patients showed a dramatic improvement during the treatment. Their mute, immobile states were reversed and they were able to speak a few coherent words. Their mental status deteriorated when the drug was withdrawn. Transient clinical improvement was noted when amantadine was reinstituted. In all patients EEG showed typical repetitive periodic sharp waves (PSW) similar to those seen in Creutzfeldt-Jacob disease. Alterations of PSW accompanied the initial clinical improvement. We speculate that amantadine acts as a central stimulant by enhancing the release of central endogenous dopamine and possibly other neurotransmitters.
Adamantanes for the treatment of neurodegenerative diseases in the presence of SARS-CoV-2. [2023]Advent of the acute respiratory coronavirus SARS-CoV-2 has resulted in the search for novel antiviral agents and in the repurposing of existing agents with demonstrated efficacy against other known coronaviruses in the search for an agent with antiviral activity for use during the COVID-19 pandemic. Adamantanes including amantadine, rimantadine, and memantine have well-established benefit in the treatment of neurodegenerative diseases including Parkinson's disease (PD), Alzheimer's disease (AD) and fatigue related to Multiple sclerosis (MS) all of which are known comorbidities related to COVID-19 Moreover, results of basic pharmacological studies both in vitro and in vivo reveal that amantadine has the potential to inhibit SARS-CoV-2 via down-regulation of host-cell proteases resulting in impaired viral genome release into the host cell and via amantadine's property as an NMDA receptor antagonist resulting in the prevention of the acute lung injury and respiratory distress that is characteristic of COVID-19. Cases suggestive of COVID-19 prophylaxis have been reported in patients with PD or MS or severe cognitive impairment treated in all cases for several months with an adamantane [amantadine or memantine] who were subsequently infected with SARS-CoV-2 confirmed by RT-PCR, and, in all cases, no signs of infectious disease were encountered. Amantadine is effective for the treatment of fatigue in MS and for the neurological complications of Traumatic Brain Injury (TBI).
The effect of amantadine on arousal and EEG patterns in Creutzfeldt-Jakob disease. [2019]In recent years, Creutzfeldt-Jakob disease (CJD) has been supposed to be of viral origin, and amantadine hydrochloride has been suggested as therapy because of its proved antiviral action. We studied nine patients with CJD (confirmed at autopsy in seven). Four were treated with amantadine hydrochloride, in dosages ranging from 3.5 to 15 mg/kg/day for an average period of 32 days. The clinical evolution of their disease was compared with that in five patients receiving only supportive maintenance therapy. The length of survival from the onset of clinical care did not differ significantly between the two groups. Nevertheless, a transient improvement in wakefulness and mentation was observed in three patients treated with amantadine, and EEG changes were observed in two, consisting above all of a reduction in the slow-wave activity and the periodic discharges (PDs). Amantadine administered intravenously did not induce any short-term changes in the PDs or the cyclic alternating pattern.
Amantadine for executive dysfunction syndrome in patients with dementia. [2013]This article reports the results of an open uncontrolled chart review study of amantadine treatment for executive dysfunction syndrome in patients with dementia. All patients admitted to the neuropsychiatry or geriatric psychiatry inpatient units of Johns Hopkins Hospital in 2000 and 2001 who were treated empirically with amantadine for executive dysfunction syndrome were included in the review. Of the 30 patients whose cases were reviewed, 17 (57%) were at least "much improved," and most patients were discharged taking amantadine, suggesting that their physicians believed that they may have benefited from it. The medication was well tolerated in this frail group of patients. Most patients were taking one or more concurrent psychotropic medications, which may have contributed to the positive outcomes. Despite its limitations, this study offers preliminary data to support a controlled trial of amantadine in patients with executive dysfunction syndrome.
A Phase 3, double-blind, placebo-controlled efficacy and safety study of ADS-5102 (Amantadine) extended-release capsules in people with multiple sclerosis and walking impairment. [2022]ADS-5102, a delayed-release, extended-release (DR/ER) amantadine, improved walking speed in MS in a Phase 2 trial.
Effects of Renal Impairment on the Pharmacokinetics of Once-Daily Amantadine Extended-Release Tablets. [2020]An extended-release formulation of amantadine (Osmolex ER™, Osmotica Pharmaceutical US LLC) was approved in February 2018 to treat Parkinson's disease and drug-induced extrapyramidal reactions in adults.
EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson's Disease. [2021]Gocovri® (amantadine) extended release capsules are approved for the treatment of dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy.
Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia. [2021]Gocovri (amantadine) extended release capsules are approved for treatment of dyskinesia and as a levodopa adjunct for OFF episodes in patients with Parkinson's disease (PD). We report treatment-related effects on non-motor symptoms (NMS) assessed as secondary outcomes in two trials using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I.
Efficacy of oral amantadine among patients hospitalised with COVID-19: A randomised, double-blind, placebo-controlled, multicentre study. [2023]Amantadine has been proposed as a treatment for COVID-19 because it shows anti-SARS-CoV-2 activity in vitro. However, to date, no controlled study has assessed the safety and efficacy of amantadine in COVID-19.