Recruiting
Phase 2

AMDX-2011P

Sponsor:

Amydis Inc.

Code:

NCT06514001

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AMDX-2011P

Study Details

Brief summary:

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).

Conditions

Alzheimer Disease

Study ID

NCT06514001

Start date

Mar 7, 2025

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: AMDX-2011P 100 milligram

AMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review

Interventions

AMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review

Primary outcome measure

  • AMDX-2011P Adverse Events Profile [ Time Frame: 8 days ]

Central Contacts and Locations

Central contacts

Locations

Associated Retina Consultants

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

More Information

Sponsor

Amydis Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • AD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amydis Inc. on 2026-08-31.