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Monoclonal Antibodies

AMDX-2011P for Alzheimer's Disease

Phase 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
Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan
Be older than 18 years old
Must not have
Prolonged QTcF (corrected QT interval by Fridericia method) (>450 ms for males and >470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days
Awards & highlights

Summary

"This trial will test how safe and effective a single dose of AMDX-2011P is for people with Alzheimer's Disease. They will look at how the drug moves through the body, its effects

Who is the study for?
This trial is for individuals with Alzheimer's Disease confirmed by a PET brain scan. Participants must be willing to undergo genetic testing and retinal imaging, and have the ability to fixate during these procedures. Those with heart rhythm issues, significant ECG abnormalities, psychological conditions likely to prevent study completion, glaucoma or certain forms of macular degeneration cannot join.
What is being tested?
The study tests AMDX-2011P administered as a single intravenous dose in people with Alzheimer's Disease. It aims to evaluate the safety, how well it's tolerated, its presence in blood over time (pharmacokinetics), and its biological effects on patients.
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, potential allergic responses, changes in heart rhythm due to infusion-related processes and other unforeseen reactions based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Alzheimer's with a positive amyloid PET scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heart's electrical activity is normal as per my last ECG.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AMDX-2011P Adverse Events Profile
Secondary study objectives
Biological Activity
Concentration of AMDX-2011P
Pharmacokinetic Analysis of AMDX-2011P

Trial Design

1Treatment groups
Experimental Treatment
Group I: AMDX-2011P 100 milligramExperimental Treatment1 Intervention
AMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review

Find a Location

Who is running the clinical trial?

Amydis Inc.Lead Sponsor
3 Previous Clinical Trials
111 Total Patients Enrolled
David Bingaman, DVM, PhDStudy DirectorAmydis Inc.
1 Previous Clinical Trials
25 Total Patients Enrolled
~10 spots leftby Dec 2024
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