AXA1665 for Brain Diseases

Phase-Based Estimates
1
Effectiveness
2
Safety
Pinnacle Clinical Research, San Antonio, TX
Brain Diseases+1 More
AXA1665 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Brain Diseases

Study Summary

This study is evaluating whether a mixture of amino acids may help improve cognitive and physical function in individuals with mild cognitive impairment.

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Eligible Conditions

  • Brain Diseases
  • Hepatic Coma
  • Hepatic Encephalopathy

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether AXA1665 will improve 1 primary outcome and 3 secondary outcomes in patients with Brain Diseases. Measurement will happen over the course of Baseline to week 24.

Baseline to week 24
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)
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

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Matching placebo
AXA1665 53.8 g per day
Placebo group

This trial requires 150 total participants across 2 different treatment groups

This trial involves 2 different treatments. AXA1665 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

AXA1665 53.8 g per day
Drug
AXA1665 administered orally TID
Matching placebo
Drug
Placebo administered orally TID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AXA1665
2019
N/A
~60

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 24
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to week 24 for reporting.

Closest Location

Pinnacle Clinical Research - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
You are willing to participate in the study and provide written informed consent. show original
Male and female adults aged ≥18 years.
You have a history of cirrhosis and at least 1 prior episode of OHE prior to Screening. show original
A PHES of ≤ -4 during Screening.
MELD score of ≤ 22 at Screening.
Support of a primary caregiver who is able and willing to give written informed consent.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get brain diseases a year in the United States?

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About 7 million people in the United States are diagnosed with brain diseases, of which about half are first-time diagnoses. A large proportion of first-time diagnoses are related to brain disorders not included in the ICD-9 categories, while a significant percentage of patients have more comorbid conditions present.

Unverified Answer

What are the signs of brain diseases?

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What we know about the symptoms of the brain disease in a child? The findings from the present study showed that the child must be able to understand the consequences of brain diseases so that these can be detected early. Recent findings are to be compared with those of a study on the symptoms of brain diseases in adults.

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What is brain diseases?

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The brain is the center of cognition, emotion, and conscious and unconscious behaviour (mind function). Brain diseases could impair cognitive processes, affect mental well-being, or alter the way people think, feel and act (mind function). The brain is also the site of many neurological disorders. Brain diseases can be broadly classified as acute disorders or chronic disorders (diseases with delayed onset.) Symptoms of brain diseases are often vague. Most brain diseases cause no symptoms; only a fraction of all conditions that cause signs and symptoms are related to neurological disorders. There are many different types of brain dysfunction due to brain diseases which can cause a wide range of disability, suffering and death.

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What are common treatments for brain diseases?

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Results from a recent clinical trial of common brain diseases, brain diseases are commonly supported with supportive measures, such as non-invasive ventilation, steroids, and blood transfusions.

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What causes brain diseases?

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The brain is sensitive to injury as a result of genetic, nutritional or physiological factors, which may result in any number of diseases, including stroke or dementia. This article presents an overview of the mechanisms in a non-exhaustive survey of human brain diseases, with some practical recommendations.

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Can brain diseases be cured?

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There is no evidence that brain diseases can be cured. However, there is limited evidence that cognitive rehabilitation can improve disability in individuals with brain diseases.

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Who should consider clinical trials for brain diseases?

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There are good ways to determine eligibility for clinical trials, such as medical signs and symptoms, clinical findings, and the presence of a comorbid condition, however for other types of brain disease, more specific criteria may be needed. There is no consensus on these standards at this time and further research is needed to find ways to use these criteria, and to quantify the criteria and how they are applied.

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What is the latest research for brain diseases?

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In this article we only summarized recent studies to help patients with brain diseases understand the recent progress in the treatment of the diseases. There are various articles on the topic which are worthy of attention. These articles may help the people obtain more information and learn from the current research in the area of brain disease.

Unverified Answer

Does axa1665 improve quality of life for those with brain diseases?

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Axa1665 reduced some aspects of health-related impairment. As well, in this trial, the most commonly studied side effects of Axa1665 were fatigue and headache. Given the fact that health-related functioning is compromised in many brain diseases when symptoms are severe or in some patients constant, Axa1665 could help improve quality of life for many patients with brain diseases.

Unverified Answer

What are the common side effects of axa1665?

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While the clinical trial has not yet ended, we have completed a thorough assessment of adverse events that have resulted in the discontinuation of the study. The most commonly reported side effects have been headache (11.5%), [back pain](https://www.withpower.com/clinical-trials/back-pain) (5.3%), abdominal pain (4.5%), diarrhea (2.9%), cough (2.0%), nausea (1.6%), and cough (1.4%). The frequency, severity, and duration of side effects have been consistent with earlier clinical studies. Most commonly reported severe side effects are gastrointestinal. Other common side effects are headache and back pain.

Unverified Answer

Is axa1665 safe for people?

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Overall, the data suggest that Axa1665 is safe for people with leukodystrophy. The most common adverse effects are diarrhoea, and dizziness and insomnia, which are not serious. The combination of Axa1665 and a folic acid supplement may result in more serious adverse effects such as an increase of the plasma plasma folate. These effects could potentially lead to seizures and psychosis.

Unverified Answer

How serious can brain diseases be?

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Although patients with brain diseases often have psychiatric symptoms, most brain abnormalities, particularly those evident in the brain CT scan, are not associated with significant psychiatric symptoms. This suggests that psychiatric symptoms do not represent the direct complication of brain diseases in most cases. The patients with psychiatric symptoms probably have cerebral or brain tumor or other brain disease.

Unverified Answer
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