Study to Detect Dendritic Cell Recruitment in Human Retina

NCT06872658 | Not Yet Recruiting

• 1 other identifier: MindImmune
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to develop an optimal method to detect the immune cells (cells that protect the human body against diseases) in association with abnormal conditions of the retina (light sensitive tissue in the back of the eye) that will be relevant to diseases such as age related macular degeneration (AMD), mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD. The main objectives of this study are:

1. 1.Establish Optimal Method for Retinal Imaging of Dendritic Cells (DCs)
2. 2.Safety and Tolerability of ICG infusion in normal healthy, older adult volunteers, in participants with AMD (Dry AMD with Geographic Atrophy (GA)), and in participants who have received a diagnosis of either Mild Cognitive Impairment (MCI) due to AD, or mild AD

Conditions

Dry Age Related Macular Degeneration; Mild Cognitive Impairment (MCI); Alzheimer Disease

Keywords

AMD; Dry Age Related Macular Degeneration; AD; MCI; Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (5)

• Determining Method to detect ICG immune cells both AMD and AD Patients

  Detecting ICG-labeled immune cells in association with retinal pathology that will be relevant to Age-Related Macular Degeneration (AMD) and to Alzheimer's disease (AD).

  Retinal Scans are completed 30 minutes prior to start of ICG infusion (Baseline),240 and 360 minutes after start of ICG infusion. Each retinal scan takes 12-15 minutes.

• Establish duration and dosage of ICG infusion

  Set duration and dosage of ICG infusion to optimize resolution of Dendritic Cells with fundus autofluorescence (FAF) imaging and/or ICG fluoroscopy.

  Retinal Scans are completed 30 minutes prior to start of ICG infusion (Baseline),240 and 360 minutes after start of ICG infusion. Each retinal scan takes 12-15 minutes.

• Establish time intervals between ICG dosing and retinal imaging

  Determine optimal time interval(s) between ICG infusion and retinal imaging to identify labeled Dendritic Cells.

  Retinal Scans are completed 30 minutes prior to start of ICG infusion (Baseline),240 and 360 minutes after start of ICG infusion. Each retinal scan takes 12-15 minutes.

• Verify locations of Dendritic Cells

  Verify location of DCs by utilizing 3D retinal SD-OCT and FAF imaging.

  Retinal Scans are completed 30 minutes prior to start of ICG infusion (Baseline),240 and 360 minutes after start of ICG infusion. Each retinal scan takes 12-15 minutes.

• Safety data analyses will be conducted on all subjects who have started the infusion of ICG

  The number and percentage of participants experiencing 1 or more AEs will be summarized by participant group, relationship to Test Product administration, and severity. AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA) terminology. Listings of participants who withdraw from the study due to an AE, serious AEs and/or death will be presented. Laboratory parameters will be summarized for each cohort using descriptive statistics and data listings of clinically significant abnormalities. Vital signs and ECG data will be summarized by changes from baseline values using descriptive statistics.

  Safety and Tolerability measures are assessed beginning from the signing of the ICF through the End of study (Telephone Follow-up Days 8-15).

Study Arms (3)

Participants with Dry AMD with GA

To determine if human phagocytic cells labeled with the near-infrared dye ICG in the periphery can subsequently be detected in association with retinal pathology in patients with Dry AMD with geographic atrophy (GA).

Healthy Older Adult Participants

To determine if human phagocytic cells labeled with the near-infrared dye ICG in the periphery can subsequently be detected in association with retinal pathology in healthy elderly patients

Participants with Mild Cognitive Impairment (MCI) due to AD or mild AD

To determine if human phagocytic cells labeled with the near-infrared dye ICG in the periphery can subsequently be detected in association with retinal pathology in patients patients diagnosed with either mild cognitive impairment (MCI) due to Alzheimer's disease (AD

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Between 2 and 15 participants, as needed to establish methods. Between one (1) and (3) of these participants will be healthy control participants without any retinal pathology. Up to six (6) Dry AMD with GA participants and up to six (6) MCI and/or mild AD participants will be enrolled in this study.

You may qualify if:

• All Study Participants
• Male or female and between the ages of 55 to 80 years old (inclusive)
• Participants are determined by the qualified investigator to be medically stable and able to understand and agree to comply with the study procedures and report for scheduled study visits.
• Participants have adequate hearing, vision, and language skills to provide informed consent and to cooperate with all retinal imaging, cognitive testing, interviews and other medical procedures as specified in the protocol. Hearing augmentation (i.e., hearing aids) are allowed.
• Participants are able to reliably communicate with study personnel about adverse events (AEs) and concomitant medications.
• Provide signed written informed consent according to institutional guidelines. Participants with mild AD must be able to provide assent and be accompanied by a relative or caregiver who is empowered to provide written consent.
• Permitted medications stable for at least 1 month prior to screening. In particular:
• Participants may take stable doses of antidepressants lacking significant anticholinergic side effects (if they are not currently depressed and do not have a history of major depression within the past year).
• Healthy Elderly Participants
• MMSE score \> 27
• CDR score = 0
• No current or past history of first-degree relative(s) with either a diagnosis of AD or suspected AD, and no subjective memory impairment with persisting worries.
• If any such test results are available, no APOE e4 allele positivity or abnormal beta-amyloid protein aggregation as assessed by blood plasma, PET imaging or CSF analyses.
• No evidence of any retinal/ocular diseases, other than myopia or hyperopia
• No evidence of any neurological / neurodegenerative diseases

You may not qualify if:

• Medical History
• Participants with a history of any anaphylactic reactions to drugs
• Participants with a history of allergic reaction to ICG
• Participants with a history of iodine sensitivity and/or allergic reaction to iodine
• Participants with a history of a clinically significant hepatic disease
• Participants with a Modified Hachinski Ischemia Scale (MHIS) score \> 2
• Participants with a known hypersensitivity to tropicamide eye drops or other anticholinergic medications
• Participants with histories of other ocular or neurologic disease that could affect the results including, but not limited to, diabetic retinopathy or glaucoma.
• Geriatric Depression Scale Short Form (GDS-S 15 Items) score \> 6.
• Target Disease Exceptions
• Any participant diagnosed to have an autoimmune disorder, including but not limited to
• Psoriasis
• Lupus
• Rheumatoid arthritis
• Crohn's disease

Sponsors & Collaborators

• MindImmune Therapeutics, Inc.: lead
• Syneos Health: collaborator
• CHU de Quebec-Universite Laval: collaborator

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Peter J Syder, PhD

  MindImmue

  STUDY DIRECTOR

Central Study Contacts

Peter J. Snyder, PhD

CONTACT

(401) 323-5838; pjsnyder@mindimmune.com

GinaMarie Tonini, MBA

CONTACT

(401) 684-0509; ginamarie.tonini@uri.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 12, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share