A Study of AMDX-2011P in Participants With Alzheimer's Disease
Recruiting · NCT06514001 · Interventional (participants receive a specific treatment) · Lead sponsor: Amydis Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AMDX-2011P
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed across 1 US state.
- Associated Retina Consultants - Phoenix, Arizona, United States