Evaluating AMDX-2011P for Alzheimer's Disease
A Phase 2, Open Label, Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimer's Disease
This study is testing a new drug called AMDX-2011P to see if it is safe and effective for people with Alzheimer's Disease after they receive a single IV dose.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amydis Inc. Industry-sponsored |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT06514001 on ClinicalTrials.gov |
What this trial studies
This open-label study aims to assess the safety, tolerability, plasma pharmacokinetics, and biological activity of a single intravenous dose of AMDX-2011P in participants diagnosed with Alzheimer's Disease. Participants will undergo retinal imaging and safety assessments before and after receiving the drug. The study will involve a single IV bolus injection followed by monitoring of safety and biological responses through blood collection and imaging evaluations.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of Alzheimer's Disease and a positive amyloid beta signal from a PET brain scan.
Not a fit: Patients with underlying conditions such as glaucoma or certain forms of age-related macular degeneration may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Alzheimer's Disease.
How similar studies have performed: While this approach is novel, similar studies targeting Alzheimer's Disease have shown promise in exploring new treatment avenues.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan 2. Must be willing to consent to genotyping for apolipoprotein E (APOE) 3. Ability to fixate and undergo retinal imaging of both eyes 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. Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination, visual field, and/or optical coherence tomography (OCT) results 3. Diagnosis of intermediate dry, wet/neovascular, or geographic atrophy forms of age-related macular degeneration (AMD) in either eye, OR as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination and/or optical coherence tomography (OCT) results 4. Clinically significant laboratory abnormalities as assessed by the investigator 5. Prolonged QTcF (corrected QT interval by Fridericia method) (\>450 ms for males and \>470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the investigator.
Where this trial is running
Phoenix, Arizona
- Associated Retina Consultants — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Matthew Lehman
- Email: info@amydis.com
- Phone: 8599050402
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.