Evaluating AMDX-2011P for Alzheimer's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Associated Retina Consultants
  Phoenix, Arizona, United States Recruiting

Study contacts

• Study coordinator: Matthew Lehman
• Email: info@amydis.com
• Phone: 8599050402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.