A Study of AMDX-2011P in Participants With CAA

Cerebral Amyloid Angiopathy Clinical Trial

Official title:

A Phase 2, Open-Label Study of AMDX-2011P as a Retinal Tracer in Participants With Cerebral Amyloid Angiopathy (CAA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709314
• Other study ID #: AMDX-2011P-001
• Secondary ID: 5SB1AG073029-02
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Amydis Inc.
• Contact: Joyce Simpauco, MPH
• Phone: 858-254-7435
• Email: joyce[@]amydis.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 cerebral amyloid angiopathy (CAA).

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 CAA. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of hereditary CAA or probable and definite symptomatic or asymptomatic sporadic CAA diagnosed through genetic testing or according to the modified Boston neuroradiological criteria, who had undergone at least one brain magnetic resonance imaging (MRI)prior to entry into study.

2. Abnormality consistent with CAA on historical MRI.

3. In general good health

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. Clinically significant laboratory abnormalities assessed by the investigator.

3. Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low-grade cervical intraepithelial neoplasia.

4. Prolonged QTcF (>450 ms for males and >470 ms for females),cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the investigator.

Related Conditions & MeSH terms

• Amyloidosis
• Cerebral Amyloid Angiopathy

Intervention

Drug:
• AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review

Locations

Country	Name	City	State
United States	Global Research Management	Glendale	California
United States	Eye Research Foundation	Newport Beach	California
United States	Associated Retina Consultants	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Amydis Inc.	National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMDX-2011P Adverse Events Profile	Incidence, nature and severity of AEs/SAEs	8 days
Secondary	Concentration of AMDX-2011P	Plasma PK Concentration (CMax)AMDX-2011P to AMDX-2011	2 hours
Secondary	Pharmacokinetic Analysis of AMDX-2011P	Area under the plasma versus time curve (AUC)	2 hours
Secondary	Biological Activity	Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.	8 days