A Study of AMDX-2011P in Participants With Alzheimer's Disease

Phase 2

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Drug: AMDX-2011P

• Registration Number: NCT06514001
• Lead Sponsor: Amydis Inc.

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.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMDX-2011P 100 milligram	AMDX-2011P	AMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review

Primary Outcome Measures

Name	Time	Method
AMDX-2011P Adverse Events Profile	8 days	Incidence, nature and severity of adverse events/serious adverse events (AEs/SAEs)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Global Research Management; 🇺🇸 Glendale, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Associated Retina Consultants; 🇺🇸 Phoenix, Arizona, United States