Probable Alzheimer's DiseaseNCT05482867
Exploratory Open Label Study for Development of a Method To Detect Dendritic Cells
An observational study of Probable Alzheimer's Disease, run by MindImmune Therapeutics, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Probable Alzheimer's Disease
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to 17 Sep 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
CNS, A Division of APEX Innovative Sciences
Long Beach, California, 90806
About this study
Official title: Exploratory Open-Label Study For the Development of a Method To Detect Dendritic Cell Recruitment in Alzheimer's Disease (DC RAD)
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).
Read the detailed description
To develop a method to detect dendritic cell recruitment in Alzheimer's disease (DC RAD), this study is designed in 2 parts.
The first part assesses the safety and efficacy of indocyanine green (ICG) in labeling peripheral immune phagocytic cells in healthy adult subjects.
The second part is designed to determine the presence of ICG in the brain of adult subjects diagnosed with Alzheimer's disease (AD). In the first part of the study, ICG will be delivered by intravenous infusion to healthy subjects to verify that peripheral immune phagocytic cells, of which DCs are a subset, can be labeled with ICG. If ICG labeling of phagocytic cells is confirmed, then in the second part of the study the presence of ICG in brain of AD patients, putatively carried in by ICG-labeled cells, will be investigated by NIRS using the INVOS 7000 cerebral oximeter.
- Conditions
- Probable Alzheimer's Disease
- Keywords
- Phase 0 Non-intervention Biomarker Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS 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 in NSS 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 in NSS 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 2A | Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly | |
| Cohort 3A, | Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects | |
| Cohort4, | Cohort 4, Probable AD patients, will receive an ICG infusion of D5W 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs)
TEAE evaluations were reported on all randomized subjects who started infusion of ICG (Day 0) through 1 Week post infusion Telephone follow-up (Day 16) All AEs were followed until resolution. The number of participants may have experienced 1 or more TEAEs per Cohort. Participant numbers include Severity, TEAEs leading to Discontinuations, TEAEs leading to Intervention Discontinuation and severity and TEAEs leading to Death.
Measured: Dosing (Day 0) through Telephone Follow-up (Day 16)
Electrocardiogram Results
The numbers of participants with overall ECG interpretations by the Investigator as Normal; Abnormal, Not Clinically significant (Abnormal NCS); and Abnormal, Clinically Significant (Abnormal CS) are completed at Screening, On Day 0, 30 minutes post start of ICG infusion and Day 2, 48 hours post start of infusion.
Measured: Screening, Day 0 and Day 2
Mean ICG Concentrations
Mean concentrations of ICG with full ranges.
Measured: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Cohorts 2A (3 subject and 3A (3 subjects) had no PK specimens drawn or analyzed at 48 hours that was specified in the a protocol a priori.
Mean concentrations of ICG, measured with full ranges reported for cohorts 1 and 4. Cohorts 2 and 2A were combined and reported as a post-hoc analysis. Cohorts 3 and 3A were combined and reported as a post-hoc analysis.
Measured: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hour
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG
Change in percentage (%) labeling of PBMCs labeled with ICG, reported as a single measure (mean and standard deviation) for the cohorts between Day 0 (prior to infusion) and Day 2 (48 hours after the start of infusion).
Measured: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG (Post Hoc Analysis)
Change in percentage (%) labeling of PBMCs labeled with ICG (Mean and Standard Deviation) reported as a single measure for the specified cohorts between Day 0 (prior to infusion) and Day 2 (48 hours after the start of infusion).
Cohorts 2 and 2A results were combined in this post hoc analysis and Cohorts 3 and 3A results were combined in this post hoc analysis.
Measured: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)
Near-infrared Spectroscopy (NIRS) Measures
The amount of ICG in brain tissue was measured by near-infrared spectroscopy (NIRS). ICG absorbs near-infrared light in the same wavelength range as hemoglobin. This enabled the use of the INVOS 7100 Regional Oximeter, which measures the amount of near-infrared light (NIR-L) absorbed by hemoglobin in brain tissue, to be used to measure ICG levels in brain tissue at times after the start of infusion, expressed as percentage change in near-infrared (NIR-L) absorbance over the baseline level of absorbance due to hemoglobin prior to the start of the ICG infusion.
Measured: Percentage change in NIR-L absorbance was measured at 60 mins. 120 mins, 150 mins, 240 mins and 48 hours after the start of the ICG infusion.
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
The amount of ICG in brain tissue was measured by near-infrared spectroscopy (NIRS). ICG absorbs near-infrared light in the same wavelength range as hemoglobin. This enabled the use of the INVOS 7100 Regional Oximeter, which measures the amount of near-infrared light absorbed (NIR-L) by hemoglobin in brain tissue, to be used to measure ICG levels in brain tissue. ICG in brain tissue at times after the start of infusion, expressed as percentage change in near-infrared light (NIR-L) absorbance over the baseline level of absorbance due to hemoglobin prior to the start of ICG infusion.
Measured: Percentage change in NIR-L absorbance was measured at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours after the start of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start28 Nov 2022
- Primary completion7 Aug 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Probable Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindImmune Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482867
- Sponsor's protocol ID
- ICG-001
- Status last verified
- Dec 2025
- First submitted
- 28 Jul 2022
- Last updated
- 8 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Open-Label Study For the Development of a Method To Detect Dendritic Cell Recruitment in Alzheimer's Disease (DC RAD)
- ClinicalTrials.gov ID
- NCT05482867
- Acronym / sponsor ID
- ICG-001
- Conditions
- Probable Alzheimer's Disease
- Keywords
- Phase 0 Non-intervention Biomarker Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- MindImmune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
To develop a method to detect dendritic cell recruitment in Alzheimer's disease (DC RAD), this study is designed in 2 parts.
The first part assesses the safety and efficacy of indocyanine green (ICG) in labeling peripheral immune phagocytic cells in healthy adult subjects.
The second part is designed to determine the presence of ICG in the brain of adult subjects diagnosed with Alzheimer's disease (AD). In the first part of the study, ICG will be delivered by intravenous infusion to healthy subjects to verify that peripheral immune phagocytic cells, of which DCs are a subset, can be labeled with ICG. If ICG labeling of phagocytic cells is confirmed, then in the second part of the study the presence of ICG in brain of AD patients, putatively carried in by ICG-labeled cells, will be investigated by NIRS using the INVOS 7000 cerebral oximeter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS 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 in NSS 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 in NSS 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 2A | – | –Cohort 2A, Three healthy adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly |
| Cohort 3A, | – | –Cohort 3A, Three healthy elderly adults, will receive an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes. If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects |
| Cohort4, | – | –Cohort 4, Probable AD patients, will receive an ICG infusion of D5W 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: Dosing (Day 0) through Telephone Follow-up (Day 16)
TEAE evaluations were reported on all randomized subjects who started infusion of ICG (Day 0) through 1 Week post infusion Telephone follow-up (Day 16) All AEs were followed until resolution. The number of participants may have experienced 1 or more TEAEs per Cohort. Participant numbers include Severity, TEAEs leading to Discontinuations, TEAEs leading to Intervention Discontinuation and severity and TEAEs leading to Death.
Electrocardiogram Results
Time frame: Screening, Day 0 and Day 2
The numbers of participants with overall ECG interpretations by the Investigator as Normal; Abnormal, Not Clinically significant (Abnormal NCS); and Abnormal, Clinically Significant (Abnormal CS) are completed at Screening, On Day 0, 30 minutes post start of ICG infusion and Day 2, 48 hours post start of infusion.
Mean ICG Concentrations
Time frame: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours
Mean concentrations of ICG with full ranges.
Mean ICG Concentrations With Full Ranges (Post Hoc Analysis)
Time frame: Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hour
Cohorts 2A (3 subject and 3A (3 subjects) had no PK specimens drawn or analyzed at 48 hours that was specified in the a protocol a priori. Mean concentrations of ICG, measured with full ranges reported for cohorts 1 and 4. Cohorts 2 and 2A were combined and reported as a post-hoc analysis. Cohorts 3 and 3A were combined and reported as a post-hoc analysis.
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG
Time frame: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)
Change in percentage (%) labeling of PBMCs labeled with ICG, reported as a single measure (mean and standard deviation) for the cohorts between Day 0 (prior to infusion) and Day 2 (48 hours after the start of infusion).
Change in Percentage (%) Labeling of Peripheral Blood Mononuclear Cells (PBMCs) Labeled With ICG (Post Hoc Analysis)
Time frame: Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing)
Change in percentage (%) labeling of PBMCs labeled with ICG (Mean and Standard Deviation) reported as a single measure for the specified cohorts between Day 0 (prior to infusion) and Day 2 (48 hours after the start of infusion). Cohorts 2 and 2A results were combined in this post hoc analysis and Cohorts 3 and 3A results were combined in this post hoc analysis.
Near-infrared Spectroscopy (NIRS) Measures
Time frame: Percentage change in NIR-L absorbance was measured at 60 mins. 120 mins, 150 mins, 240 mins and 48 hours after the start of the ICG infusion.
The amount of ICG in brain tissue was measured by near-infrared spectroscopy (NIRS). ICG absorbs near-infrared light in the same wavelength range as hemoglobin. This enabled the use of the INVOS 7100 Regional Oximeter, which measures the amount of near-infrared light (NIR-L) absorbed by hemoglobin in brain tissue, to be used to measure ICG levels in brain tissue at times after the start of infusion, expressed as percentage change in near-infrared (NIR-L) absorbance over the baseline level of absorbance due to hemoglobin prior to the start of the ICG infusion.
Near-infrared Spectroscopy (NIRS) Measures (Post-hoc Analysis)
Time frame: Percentage change in NIR-L absorbance was measured at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours after the start of infusion
The amount of ICG in brain tissue was measured by near-infrared spectroscopy (NIRS). ICG absorbs near-infrared light in the same wavelength range as hemoglobin. This enabled the use of the INVOS 7100 Regional Oximeter, which measures the amount of near-infrared light absorbed (NIR-L) by hemoglobin in brain tissue, to be used to measure ICG levels in brain tissue. ICG in brain tissue at times after the start of infusion, expressed as percentage change in near-infrared light (NIR-L) absorbance over the baseline level of absorbance due to hemoglobin prior to the start of ICG infusion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Probable Alzheimer's Disease, run by MindImmune Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) (time frame: Dosing (Day 0) through Telephone Follow-up (Day 16)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.