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Retinal Tracer
AMDX2011P for Neurodegenerative Disease (PROBE Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Amydis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours
Awards & highlights
PROBE Trial Summary
This trial is testing an AMDX-2011P, a dye that could help diagnose degenerative diseases like Parkinson's and ALS.
Eligible Conditions
- Parkinson's Disease
- Amyotrophic Lateral Sclerosis
PROBE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AMDX-2011P adverse events profile
Secondary outcome measures
Concentration of AMDX-2011P
Dental Deposits
Pharmacokinetic Analysis of AMDX-2011P
PROBE Trial Design
4Treatment groups
Experimental Treatment
Group I: AMDX2011P 50mgExperimental Treatment1 Intervention
AMDX2011P 50mg (2ml) single bolus injection intravenous for diagnostic review
Group II: AMDX2011P 25mgExperimental Treatment1 Intervention
25mg (1ml) single bolus injection intravenous for diagnostic review
Group III: AMDX2011P 200mgExperimental Treatment1 Intervention
AMDX2011P 200mg (6-8ml) single bolus injection intravenous for diagnostic review
Group IV: AMDX2011P 100mgExperimental Treatment1 Intervention
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
Find a Location
Who is running the clinical trial?
Amydis Inc.Lead Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
Masoud Mokhtarani, MDStudy ChairAmydis Inc.
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with ALS and show signs of nerve problems in both upper and lower body.If you have Parkinson's disease, you can't have symptoms that are caused by other conditions like medication side effects or metabolic disorders.You have important abnormal test results as determined by the doctor.You have had cancer that was not completely removed, except for certain types of skin cancer or a specific type of cervical condition.Your heart's electrical activity is abnormal or your heart takes too long to recover between beats.You have an eye condition that makes it hard to see and measure certain spots in your eye.You have been diagnosed with Parkinson's disease by a doctor using specific criteria and have a certain level of disease severity based on a scale.
Research Study Groups:
This trial has the following groups:- Group 1: AMDX2011P 100mg
- Group 2: AMDX2011P 50mg
- Group 3: AMDX2011P 200mg
- Group 4: AMDX2011P 25mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned AMDX2011P for public consumption?
"Our team assigns a rating of 1 to AMDX2011P as this is still in its initial stage, and thus there has been minimal research regarding efficacy and safety."
Answered by AI
How many people are engaged in this clinical experiment?
"That is correct. According to the most recent updates on clinicaltrials.gov, this medical trial began recruiting patients since August 24th 2022 and has been actively searching for participants since then. Currently, 36 volunteers are needed at 2 different locations."
Answered by AI
Are any vacancies still available for participants in this trial?
"Affirmative. According to clinicaltrials.gov, this study has been open for recruitment since August 24th 2022 and was last updated on October 25th 2022. There is a need for 36 participants at 2 locations across the country."
Answered by AI
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