A Study of AMDX-2011P in Participants With CAA

Last updated: July 29, 2024
Sponsor: Amydis Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Alzheimer's Disease

Amyloidosis

Treatment

AMDX-2011P

Clinical Study ID

NCT05709314
AMDX-2011P-001
5SB1AG073029-02
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Abnormality consistent with CAA on historical MRI.

  3. In general good health

Exclusion

Exclusion Criteria:

  1. Presence of any underlying physical or psychological medical condition that, in theopinion of the investigator, would make it unlikely that the participant willcomplete 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 theexception of completely excised non-melanoma skin cancer or low-grade cervicalintraepithelial neoplasia.

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

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: AMDX-2011P
Phase: 2
Study Start date:
July 09, 2024
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Global Research Management

    Glendale, California 91204
    United States

    Active - Recruiting

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • California Eye Specialists

    Pasadena, California 91107
    United States

    Site Not Available

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