Exploratory Open Label Study for Development of a Method To Detect Dendritic Cells

NCT05482867 | Unknown

• 1 other identifier: ICG-001
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proof-of-concept study designed to confirm that human phagocytic cells can be labeled with the near-infrared dye indocyanine green (ICG) and the presence of the labeled cells 48 hours later in cerebral cortex can be inferred using near infrared spectroscopy (NIRS).

Conditions

Probable Alzheimer's Disease

Keywords

Phase 0 Non-intervention Biomarker Study

Outcome Measures

Primary Outcomes (2)

• Pharmacodynamic Assessments

  Determination of the percent of PBMCs labeled with ICG as measured by appropriate analytical methods. After ICG infusion, determination if there is a NIRS signal in the cortex that is higher than the baseline signal recorded before ICG infusion. The distribution of NIRS signals will be examined across the study population.

  Day 0 and Day 2

• Safety Analysis

  Safety analyses will be conducted on all subjects who have started infusion of ICG. The number and percentage of subjects experiencing 1 or more AEs will be summarized by infusion rate, relationship to timing of ICG infusion and severity. AEs and SAE and study withdrawals are characterized. Laboratory, ECG and vital signs are to summarized as changes from baseline values using descriptive statistics.

  Day 0, Day 2 and 1 Week Telephone Follow-up

Study Arms (4)

Cohort 1

Cohort 1, healthy adults (n = 5), will receive an ICG infusion of 1 mg/min for 120 minutes.

Cohort 2

If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), will receive an ICG infusion of 2 mg/min for 120 minutes. If there are no dose limiting adverse events and there is evidence of ICG-labeling of PBMCs, the 2 mg/min infusion rate will be used for the remainder of the study.

Cohort 3

Cohort 3, healthy elderly adults, will receive an ICG infusion of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed in the satellite group, then a further 10 healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3).

Cohort 4

Cohort 4, AD patients, will receive an ICG infusion of 2 mg/min for 120 minutes. The first 5 subjects will serve as a satellite group. If no adverse effects are observed, then a further 10 AD patients will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 4). Recruitment of AD patients will begin if there are no dose limiting adverse effects observed in the satellite group of healthy elderly.

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy Adult subjects: Male or female and between the ages of 21 to 55 inclusive. Healthy Elderly subjects: Male or female and between the ages of 65 to 90 inclusive. Alzheimer's patients: Male or female and between the ages of 50 to 90 inclusive.

You may qualify if:

• All Healthy Subjects:
• Subjects are determined by the investigator to be medically stable and expected to complete the trial as designed.
• Subjects have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol.
• Subjects are able to understand and agree to comply with the study procedures and report for scheduled office visits.
• Subjects are able to reliably communicate with study personnel about adverse events (AEs) and concomitant medications.
• Signed written informed consent according to institutional guidelines.
• Healthy Adult subjects: Male or female and between the ages of 21 to 55 inclusive.
• Healthy Elderly subjects: Male or female and between the ages of 65 to 90 inclusive MMSE score \> 26.
• Alzheimer's Subjects: Male or female and between the ages of 50 to 90 inclusive. Patients satisfying the criteria for the clinical diagnosis of probable AD based on National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). MMSE score of \> 16 and Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4.

You may not qualify if:

• Sex and Reproductive Status:
• Women who test positive for pregnancy.
• Pre-menopausal women who are not practicing two methods of birth control for 3 months prior and a week after the ICG infusion.
• Medical History:
• Subjects with a history of any anaphylactic reactions.
• Subjects with a history of allergic reaction to ICG.
• Subjects with a history of iodine sensitivity and/or allergic reaction to iodine.
• Subjects with a history of a clinically significant hepatic disease.
• Target Disease Exceptions:
• Any subject diagnosed to have an autoimmune disorder.
• Any subject who has any unstable cardiovascular (included uncontrolled hypertension), pulmonary, or GI disease.
• For Alzheimer's patients, a medical condition other than AD that could explain or contribute significantly to the patient's dementia.
• Concurrent Medications:
• Any subject who is immunocompromised at screening including taking medications that are systemic immunosuppressives including corticosteroids but not NSAIDS.
• Any subject currently prescribed a biologic immunosuppressive therapy or having taken such therapy in the prior 3 months.

Sponsors & Collaborators

• MindImmune Therapeutics, Inc.: lead

Study Sites (1)

CNS, A Division of APEX Innovative Sciences

Long Beach, California, 90806, United States

RECRUITING

Central Study Contacts

Frank S Menniti, PhD

CONTACT

860-271-9706; mennitifs@mindimmune.com

Study Design

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

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: November 9, 2022
• Primary Completion: June 15, 2023
• Study Completion: July 15, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)