Study to Detect Dendritic Cell Recruitment in Human Retina
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-80
SponsorMindImmune Therapeutics, Inc.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
15 Participants
are grouped into 3 trial groupsGroup A: Participants with Dry AMD with GA
Group B: Healthy Older Adult Participants
Group C: Participants with Mild Cognitive Impairment (MCI) due to AD or mild AD
Trial outcomes
Primary outcomes
1
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).
Time frame
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.2
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.
Time frame
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.3
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.
Time frame
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.4
Verify locations of Dendritic Cells
Verify location of DCs by utilizing 3D retinal SD-OCT and FAF imaging.
Time frame
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
MindImmune Therapeutics, Inc.
Lead sponsor
Syneos Health
Collaborator
CHU de Quebec-Universite Laval
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: