A Study of AMDX-2011P in Participants With Alzheimer's Disease
A Phase 2, Open Label, Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimer's Disease
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 alzheimer-disease
Started Mar 2025
Shorter than P25 for phase_2 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedStudy Start
First participant enrolled
March 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
February 13, 2026
February 1, 2026
1.5 years
July 17, 2024
February 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
AMDX-2011P Adverse Events Profile
Incidence, nature and severity of adverse events/serious adverse events (AEs/SAEs)
8 days
Secondary Outcomes (3)
Concentration of AMDX-2011P
2 hours
Pharmacokinetic Analysis of AMDX-2011P
2 hours
Biological Activity
8 days
Study Arms (1)
AMDX-2011P 100 milligram
EXPERIMENTALAMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review
Interventions
AMDX-2011P single bolus injection intravenous for diagnostic review
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amydis Inc.lead
Study Sites (1)
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2024
First Posted
July 23, 2024
Study Start
March 7, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
February 13, 2026
Record last verified: 2026-02