Status:
RECRUITING
A Study of AMDX-2011P in Participants With Alzheimer's Disease
Lead Sponsor:
Amydis Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with Alzheimer's Disease (AD).
Detailed Description
This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan
- Must be willing to consent to genotyping for apolipoprotein E (APOE)
- Ability to fixate and undergo retinal imaging of both eyes
Exclusion
- Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant will complete the study per protocol
- Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination, visual field, and/or optical coherence tomography (OCT) results
- Diagnosis of intermediate dry, wet/neovascular, or geographic atrophy forms of age-related macular degeneration (AMD) in either eye, OR as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination and/or optical coherence tomography (OCT) results
- Clinically significant laboratory abnormalities as assessed by the investigator
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06514001
Start Date
July 1 2024
End Date
March 1 2025
Last Update
July 25 2024
Active Locations (3)
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1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
2
Global Research Management
Glendale, California, United States, 91204
3
Eye Research Foundation
Newport Beach, California, United States, 92663