A Study of AMDX-2011P in Participants With CAA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-09

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cerebral Amyloid Angiopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Phase 2, open-label, single arm, masked endpoint multicenter study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AMDX-2011P 100 mg

AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review

Group Type EXPERIMENTAL

AMDX-2011P

Intervention Type DRUG

AMDX-2011P single bolus injection intravenous for diagnostic review

Interventions

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AMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No