Glow-in-the-Dark dye could reveal immune activity in Alzheimer's brains
NCT ID NCT05482867
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This study explores whether a dye called indocyanine green (ICG) can be used to track immune cells in the brain of people with Alzheimer's. Participants receive an ICG infusion, and a special light device measures the dye in the brain after 48 hours. The goal is to develop a non-invasive method to study immune cell activity, which may help understand Alzheimer's better. The trial includes both healthy volunteers and people with probable Alzheimer's.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- indocyanine green (ICG)
- What this could lead to
- If successful, this method could help researchers see how immune cells behave in Alzheimer's, potentially leading to earlier detection or new treatments.
- What could go wrong
- This is an early, small study focused on developing a technique, not treating the disease. The method may not work as hoped or may not be useful in practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
46 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Sep 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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21 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 between 15 and 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) . OR 6 months documented cognitive decline by physician OR Amyloid or Tau pathology confirmed by PET scan with ligand. MMSE score between 16 and 25 and Modified Hachinski Ischemia Scale (MHIS) score of ≤ 4. Exclusion Criteria: 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 including (Psoriasis, Lupus, Rheumatoid arthritis, Crohn's disease, multiple sclerosis, and alopecia areata). * 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. Physical and Laboratory Test Findings at Screening: * Any subject with uncontrolled hypertension at screening. * Any subject with hepatic or hematological abnormalities at screening. * Any subject who has a known infection with a human immunodeficiency virus.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CNS, A Division of APEX Innovative Sciences
Long Beach, California, 90806, United States
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