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Amino Acid Mixture
AXA1665 53.8 g per day for Encephalopathy (EMMPOWER Trial)
Phase 2
Waitlist Available
Led By Andres Duarte-Rojo, M.D.
Research Sponsored by Axcella Health, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willing to participate in the study and provide written informed consent.
Male and female adults aged ≥18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
EMMPOWER Trial Summary
This study is evaluating whether a mixture of amino acids may help improve cognitive and physical function in individuals with mild cognitive impairment.
Eligible Conditions
- Encephalopathy
EMMPOWER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEMMPOWER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)
Secondary outcome measures
Impact on physical function assessed by Liver Frailty Index (a composite measure of hand grip strength, balance and ability to stand up from a chair)
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Time to and frequency of recurrent overt hepatic encephalopathy
EMMPOWER Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXA1665 53.8 g per dayExperimental Treatment1 Intervention
AXA1665 administered orally TID
Group II: Matching placeboPlacebo Group1 Intervention
Placebo administered orally TID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXA1665
2019
N/A
~60
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Who is running the clinical trial?
Axcella Health, IncLead Sponsor
7 Previous Clinical Trials
524 Total Patients Enrolled
Andres Duarte-Rojo, M.D.Principal InvestigatorUniversity of Pittsburgh
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
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