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 tests a new drug called AMDX-2011P, given through an IV injection, in people with cerebral amyloid angiopathy (CAA). The study will check how safe the drug is, how it moves through the blood, and its effects on the body. Special attention will be given to changes in the eyes.

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.

What makes the drug AMDX-2011P unique for treating cerebral amyloid angiopathy?

There is no specific treatment for cerebral amyloid angiopathy, making AMDX-2011P potentially novel in addressing this condition. Existing research does not provide details on AMDX-2011P's mechanism or components, but its development suggests a new approach compared to the lack of current treatments. ^{1 2 3 4 5}

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. France pubmed.ncbi.nlm.nih.gov

[Cerebral amyloid angiopathy]. [2010]

2. Chile pubmed.ncbi.nlm.nih.gov

[Amyloid angiopathy brain hemorrhage]. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic modelling for the simultaneous assessment of perfusion and 18F-flutemetamol uptake in cerebral amyloid angiopathy using a reduced PET-MR acquisition time: Proof of concept. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Perfusion-weighted MRI in cerebral amyloid angiopathy-related transient focal neurological episodes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cerebral amyloid angiopathy, cerebral microbleeds and implications for anticoagulation decisions: The need for a balanced approach. [2021]