Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-02 @ 3:01 AM
Study NCT ID:
NCT06872658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-12
First Post:
2025-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Detect Dendritic Cell Recruitment in Human Retina
Sponsor:
MindImmune Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Exploratory Open-Label Study for the Development of a Method to Detect Dendritic Cell Recruitment in the Human Retina at Sites of Inflammatory Disease and Complement System Activation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ICG-002
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. Establish Optimal Method for Retinal Imaging of Dendritic Cells (DCs)
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
The main objectives of this study are:
1. Establish Optimal Method for Retinal Imaging of Dendritic Cells (DCs)
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
Detailed Description:
This methods development pilot study is intended 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 two cohorts of participants: 1) patients with Dry AMD with geographic atrophy (GA), N = 2-6; and 2) patients diagnosed with either mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD, N = 2-6. Conversely, it is hypothesized that these cells will be largely absent in healthy control participants (N = 2-3). For both disease conditions, retinal pathology includes inclusions that contain amyloid plaques, areas of retinal thinning and neuronal loss, damage to the RPE and choroid, and changes in vascular structure. Accumulation of ICG-labeled cells should be seen close to the border(s) of GA in the Dry AMD participants. The imaging results for each participant will be reviewed by the study team to modify the imaging approach for the next participant. A maximum of fifteen (15) subjects will be recruited for participation, and a maximum of 3 of these participants will be healthy control participants without any retinal pathology.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: