Alzheimer Disease
Conditions
Keywords
AD
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).
Detailed description
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.
Interventions
DRUGAMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review
Sponsors
Amydis Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 determined by an ophthalmologist as a clinical investigator, based on results from the eye examination, visual field, and/or optical coherence tomography (OCT) results 3. 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 4. Clinically significant laboratory abnormalities as assessed by the investigator 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AMDX-2011P Adverse Events Profile | 8 days | Incidence, nature and severity of adverse events/serious adverse events (AEs/SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of AMDX-2011P | 2 hours | Plasma Pharmacokinetic (PK) Concentration (CMax) AMDX-2011P to AMDX-2011 |
| Pharmacokinetic Analysis of AMDX-2011P | 2 hours | Area under the plasma versus time curve (AUC) |
| Biological Activity | 8 days | Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration |
Countries
United States
Contacts
CONTACTMatthew Lehman
Outcome results
None listed