Amydis Inc.
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).
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 with AD. Assessments of retinal images will be conducted by central masked assessors. Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.
Inclusion Criteria: 1. Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan 2. Must be willing to consent to genotyping for apolipoprotein E (APOE) 3. Ability to fixate and undergo retinal imaging of both eyes Exclusion Criteria: 1. 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 2. Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determi…
AMDX-2011P single bolus injection intravenous for diagnostic review
Arctuva estimate
Verify or correct the compensation shown for this listing.