AMDX-2011P for Cerebral Amyloid Angiopathy

Recruiting at 3 trial locations

Overseen By Joyce Simpauco, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amydis Inc.

Disqualifiers: Active malignancy, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of a one-time IV dose of a treatment called AMDX-2011P for individuals with cerebral amyloid angiopathy (CAA). CAA involves protein buildup in the brain's blood vessels, potentially causing bleeding or other issues. The trial targets individuals diagnosed with CAA through genetic testing or specific brain scans, who are otherwise healthy. Participants should have an MRI showing signs consistent with CAA. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that AMDX-2011P is likely to be safe for humans?

Research has shown that AMDX-2011P has already been tested in humans. An earlier trial found the treatment safe enough for further study, indicating it was generally well-tolerated and did not cause major issues. The current trial aims to learn more about its safety when administered as a single intravenous (IV) dose to people with cerebral amyloid angiopathy (CAA), a condition affecting blood vessels in the brain. Additional data will help confirm how well participants handle the treatment and identify potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AMDX-2011P because it offers a novel approach for treating Cerebral Amyloid Angiopathy (CAA). Unlike most treatments that focus on managing symptoms, AMDX-2011P is designed as a diagnostic tool, providing insights into the condition's progression by targeting amyloid deposits directly in the brain's blood vessels. This innovative method may allow for more precise treatment planning, potentially improving outcomes for patients with CAA.

What evidence suggests that AMDX-2011P might be an effective treatment for cerebral amyloid angiopathy?

Research shows that AMDX-2011P is being tested as a new treatment for cerebral amyloid angiopathy (CAA) in this trial. This condition occurs when a protein called amyloid builds up in the brain's blood vessels, potentially causing bleeding. Participants will receive AMDX-2011P, which acts as a tracer to identify these amyloid deposits. Early results suggest this could help doctors better understand and treat CAA. Although data on its effectiveness remains limited, the trial focuses on how well the drug can locate and interact with amyloid in the brain. This could lead to improved methods for diagnosing and managing the condition. ^{1 2 3 4 6}

Who Is on the Research Team?

David Bingaman, DVM, PhD

Principal Investigator

Amydis Inc.

Are You a Good Fit for This Trial?

Adults diagnosed with hereditary or sporadic Cerebral Amyloid Angiopathy (CAA) who can undergo retinal imaging and have no other causes of cerebral hemorrhage. Participants must not be pregnant, breastfeeding, or have a recent history of malignancy. They should agree to use contraception and avoid sperm or oocyte donation for specified periods post-study drug administration.

Inclusion Criteria

Abnormality consistent with CAA on historical MRI

In general good health

I have been diagnosed with hereditary or sporadic CAA, confirmed by genetic testing or MRI according to Boston criteria.

Exclusion Criteria

I have not had cancer in the last 5 years, except for certain skin cancers or low-grade cervical changes.

Clinically significant laboratory abnormalities assessed by the investigator

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single intravenous bolus injection of AMDX-2011P followed by safety assessments, retinal imaging, and PK blood collection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and biological activity assessments

8 days

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AMDX-2011P

Trial Overview The trial is testing the safety and tolerability of AMDX-2011P, an investigational retinal tracer administered intravenously once to patients with CAA. The study involves monitoring participants' reactions after receiving this potential new diagnostic tool.

How Is the Trial Designed?

Group I: AMDX-2011P 100 mg Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Amydis Inc.

Lead Sponsor

Trials

4

Recruited

140+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05709314

A Study of AMDX-2011P in Participants With CAA The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05709314?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(%22Cerebral%20Amyloid%20Angiopathy%22))&rank=7

NCT05709314 | A Study of AMDX-2011P in Participants With CAA A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

3. withpower.com withpower.com/trial/phase-2-cerebral-amyloid-angiopathy-familial-1-2023-6e123

AMDX-2011P for Cerebral Amyloid Angiopathy This trial tests a new drug called AMDX-2011P, given through an IV injection, in people with cerebral amyloid angiopathy (CAA).

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/amydis-cerebral-amyloid-angiopathy/

Amydis begins enrolment in cerebral amyloid angiopathy ... The trial will evaluate the pharmacokinetics, tolerability, activity, and safety of escalating intravenous doses of AMDX-2011P in CAA patients.

5. synapse-patsnap-com.libproxy1.nus.edu.sg synapse-patsnap-com.libproxy1.nus.edu.sg/drug/21060bf0a835488fac99ae9e9af55e73

AMDX2011P - Drug Targets, Indications, Patents - Synapse A Phase 2, Open-Label Study of AMDX-2011P as a Retinal Tracer in Participants With Cerebral Amyloid Angiopathy (CAA)

6. amydis.com amydis.com/2023/02/21/amydis-announces-enrollment-of-cerebral-amyloid-angiopathy-participants-in-phase-1-2a-retinal-tracer-trial/

Amydis Announces Enrollment of Cerebral Amyloid ... CAA develops in up to 23% of the general population with aging, and it occurs at a higher rate of ~48% in people with Alzheimer's disease due to ...