Health TrialsbyHealthPanel

A Study of AMDX-2011P in Participants With Alzheimer's Disease

ConditionAlzheimer Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAmydis Inc.

About this trial

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 Alzheimer's Disease (AD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan

Must be willing to consent to genotyping for apolipoprotein E (APOE)

Ability to fixate and undergo retinal imaging of both eyes

Disqualifiers

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

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

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

Clinically significant laboratory abnormalities as assessed by the investigator

Trial design

Design model

Single group

Treatments tested in this trial

  • AMDX-2011P

    Drug

    AMDX-2011P single bolus injection intravenous for diagnostic review

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: AMDX-2011P 100 milligramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AMDX-2011P Adverse Events Profile

Incidence, nature and severity of adverse events/serious adverse events (AEs/SAEs)

Time frame
8 days

Secondary outcomes

1

Concentration of AMDX-2011P

Plasma Pharmacokinetic (PK) Concentration (CMax) AMDX-2011P to AMDX-2011

Time frame
2 hours
2

Pharmacokinetic Analysis of AMDX-2011P

Area under the plasma versus time curve (AUC)

Time frame
2 hours
3

Biological Activity

Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration

Time frame
8 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amydis Inc.

Lead sponsor

Source ClinicalTrials.gov
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