A Study of AMDX-2011P in Participants With Alzheimer's Disease
Recruiting now · Phase 2
Conditions studied: Alzheimer Disease
In brief
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).
Key facts
- Study ID
- NCT06514001
- Run by
- Amydis Inc.
- People needed
- 25
- Starts
- 2025-03-07
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Associated Retina Consultants — Phoenix, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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