A Study of AMDX-2011P in Participants With Alzheimer's Disease
Amydis Inc. · NCT06514001
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 25
- US sites recruiting
- 1
- Study start
- March 7, 2025
- Record last updated
- August 31, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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).
Being studied: AMDX-2011P
Conditions: Alzheimer Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Associated Retina Consultants
Phoenix, AZ 85020
Site contact: Mallory Mintert · mallory.mintert@doctrials.com
Study contacts (from the official record)
- Matthew Lehman · 8599050402 · info@amydis.com
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