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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | ||
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Screening, Day 0 and Day 2 |
| Mean ICG Concentrations | Mean concentrations of ICG with full ranges. | 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. | 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). |
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Inclusion Criteria:
All Healthy Subjects:
Exclusion Criteria:
Sex and Reproductive Status:
Medical History:
Target Disease Exceptions:
Concurrent Medications:
Physical and Laboratory Test Findings at Screening:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CNS, A Division of APEX Innovative Sciences | Long Beach | California | 90806 | United States |
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A total of 51 subjects were planned to be enrolled in the study, including 18 healthy adults (5 in Cohort 1, 10 in Cohort 2, and 3 in Cohort 2a, along with 18 healthy elderly (15 in Cohort 3 and 3 in Cohort 3a), and 15 AD patients (in Cohort 4). Final enrollment for Cohort 3 (15 subjects) and Cohort 4 (10 Subjects) with a total enrollment (N = 46) subjects
One Investigator at one study center in the United States (Collaborative Neuroscience Research, LLC, Long Beach 90806, CA, USA) Study is where all Patients were recruited, screened and if qualified were enrolled and treated according to the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes. |
| FG001 | 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. |
| FG002 | 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 (N=3). If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly |
| FG003 | 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 (N=3). If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects |
| FG004 | 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 planned further 5 healthy elderly adults will receive a 2 mg/min ICG infusion. An additional 10 additional elderly were enrolled after the satellite group (n = 15) total for Cohort 3). |
| FG005 | 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 5 AD patients will receive a 2 mg/min ICG infusion were planned pre-enrollment. Only 5 additional Probable AD subjects were enrolled after the satelite group (n = 10) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Number of Subjects (Planned and Analyzed):
A total of 51 subjects were planned to be enrolled in the study, A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 46 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 41 completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Cohort 1, healthy adults (n = 5), received an ICG infusion in NSS of 1 mg/min for 120 minute |
| BG001 | Cohort 2 | If no dose limiting adverse effects are observed in Cohort 1, then Cohort 2, healthy adults (n = 10), received 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | TEAEs are presented as total numbers per Cohort. | Posted | Number | participants | Dosing (Day 0) through Telephone Follow-up (Day 16) |
|
The study collection period begins after the ICF is signed through Study Day 16 .
AEs were collected includes drug treatment, type of event, time of onset, dose, investigator-specified assessment of severity and relationship to investigational product, time of resolution of the event, seriousness, as well as any required treatments or evaluations, and outcome. Any medical condition that is present at the time that the subject is screened but does not deteriorate should not be reported as an AE. All AEs were followed to adequate resolution.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Cohort 1, healthy adults (n = 5), will receive an ICG infusion in NSS of 1 mg/min for 120 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MeDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank S. Menniti, Ph.D., Chief Science Officer | MindImmune Therapeutics, Inc. | 860 271 9706 | mennitifs@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2024 | Feb 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2024 | Feb 3, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 13, 2024 | Feb 3, 2025 | ICF_002.pdf |
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| 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. |
| 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. | 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. | 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. | 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 |
| BG002 | Cohort 2A | Cohort 2A, Three healthy adults, received an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes (N = 3) If no adverse effects are observed with D5W infusion material then proceed to Cohort 3A healthy elderly |
| BG003 | Cohort 3A, | Cohort 3A, Three healthy elderly adults, receives an ICG in D5W (change in IV material) infusion of 2 mg/min for 120 minutes (N = 3). If no adverse effects are observed with D5W infusion material then proceed to Cohort 4 of probable AD subjects |
| BG004 | Cohort 3 | Cohort 3, healthy elderly adults, received 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 additional healthy elderly adults received a 2 mg/min ICG infusion (n = 15) total for Cohort 3) |
| BG005 | Cohort4, | Cohort 4, Probable AD patients, received 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 5 AD patients will receive a 2 mg/min ICG infusion (n = 10) 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. |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | The following subjects were eligible to be enrolled in the study:
| A total of 117 subjects (46 healthy adults, 36 healthy elderly, and 35 AD patients) were screened, and 41 subjects were assigned into cohorts (5 into Cohort 1, 10 into Cohort 2, 3 into Cohort 2a, 15 into Cohort 3, 3 into Cohort 3a, and 10 into Cohort 4), of whom all 46 completed the study. | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilograms |
|
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. |
| OG002 | 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 |
| OG003 | 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 |
| OG004 | 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). |
| OG005 | 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 5 AD patients will receive a 2 mg/min ICG infusion (n = 10 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. |
|
|
| Primary | 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. | All ECG Results per Cohort are listed as Normal, Abnormal Not Clinically Significant (NCS) and Clinically Signiant (CS) at specified time points. | Posted | Number | participants | Screening, Day 0 and Day 2 |
|
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| Primary | Mean ICG Concentrations | Mean concentrations of ICG with full ranges. | For Cohort 2 (10 subjects) at 60 minutes and 120 minutes time points only 9 subjects were analyzed. For Cohort 3 (15 subjects) at 120 mins and 150 mins time points only 14 subjects were analyzed. In Cohort 4 (10 subjects) at 240 mins and 48 hours only 9 subjects were analyzed. At 48 hours Cohorts 2A (3 subjects) and 3A (3 subjects) had no specimens drawn or analyzed specified in the protocol a priori | Posted | Mean | Full Range | ng/mLs | Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hours |
|
|
|
| Primary | 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. | PK results for Cohorts 2 and 2A the were combined in a Post Hoc for analysis with results between the NSS and D5W infused . PK results for Cohorts 3 and 3A were also combined in a Post Hoc analysis between the NSS and D5W infused .At 48 hours Cohorts 2A (3 subjects) and 3A (3 subjects) had no specimens drawn or analyzed specified in the protocol a priori. | Posted | Mean | Full Range | ng/mLs | Post Dosing time points: at 60 mins, 120 mins, 150 mins, 240 mins and 48 hour |
|
|
|
| Primary | 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). | Cohort 1 has only 4 subjects with results, Cohort 2A has only 2 subjects with results, Cohort 3A has only one subject with a result with no standard deviation and Cohort 4 has 9 subjects with results. | Posted | Mean | Standard Deviation | % of labeled PBMCs | Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing) |
|
|
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| Primary | 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. | Cohorts 2 and 2A results were combined in a between the NSS and D5W infused. Cohorts 3 and 3A results also were combined in a Post Hoc analysis between the NSS and D5W infused. | Posted | Mean | Standard Deviation | % of labeled PBMCs | Change between Day 0 (prior to infusion) and Day 2 (48 hours from the start of the initial dosing) |
|
|
|
| Primary | 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. | The mean and standard deviation for the percentage change in NIR-L absorbance at each time point after the start of infusion were calculated for each cohort. | Posted | Mean | Standard Deviation | Percentage change in NIR-L absorbance | 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. |
|
|
|
| Primary | 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. | The mean and standard deviation percentage change in NIR-L absorbance was calculated for each time point after the start of ICG infusion. Results for Cohorts 2 and 2A and Cohorts 3 and 3A, the NSS and D5W infusion groups, were combined. Cohorts 2 and 2A and Cohorts 3 and 3A results were combined between the two NSS and D5W infused groups. | Posted | Mean | Standard Deviation | Percentage change in NIR-L absorbance | 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 |
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| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 6 | 10 |
| EG002 | 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 more healthy elderly adults will receive a 2 mg/min ICG infusion (n = 15 total for Cohort 3). | 0 | 15 | 0 | 15 | 7 | 15 |
| EG003 | 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 | 0 | 3 | 0 | 3 | 1 | 3 |
| EG004 | 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 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG005 | 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 5 more AD patients will receive a 2 mg/min ICG infusion (n = 10 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. | 0 | 10 | 0 | 10 | 2 | 10 |
| Dizzyness | Nervous system disorders | MeDRA 25.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MeDRA 25.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MeDRA 25.0 | Systematic Assessment |
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| Blood Pressure Increase | Investigations | MeDRA 25.0 | Systematic Assessment |
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| Blood Bilirubin Increase | Investigations | MeDRA 25.0 | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MeDRA 25.0 | Systematic Assessment |
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| Infusion Site Extravastion | General disorders | MeDRA 25.0 | Systematic Assessment |
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| Infusion Site Pain | General disorders | MeDRA 25.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MeDRA 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MeDRA 25.0 | Systematic Assessment |
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| Abnormal Feces | Gastrointestinal disorders | MeDRA 25.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MeDRA 25.0 | Systematic Assessment |
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| Pruitus | Skin and subcutaneous tissue disorders | MeDRA 25.0 | Systematic Assessment |
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| Skin Discoloration | Skin and subcutaneous tissue disorders | MeDRA 25.0 | Systematic Assessment |
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| Skin Irratation | Skin and subcutaneous tissue disorders | MeDRA 25.0 | Systematic Assessment |
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| Vision Blurred | Eye disorders | MeDRA 25.0 | Systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | MeDRA 25.0 | Systematic Assessment |
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| Abnormal ECGs NCS at Screening |
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| Abnormal ECGs CS at Screening |
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| 30 Minutes Pre ICG Infusion Normal ECG |
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| 30 Minutes Pre ICG Infusion Abnormal NCS ECG |
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| 30 Minutes Pre ICG Infusion abnormal CS ECG |
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| 30 minutes post infusion Normal ECG Post infusion |
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| 30 minutes post infusion Abnormal NCS ECG Post infusion |
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| 30 minutes post infusion Abnormal CS ECG |
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| Day 2 (48 hours) Post ICG Normal ECG |
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| Day 2 (48 hours) Post ICG Infusion Abnormal CNS ECG |
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| Day 2 (48 hours) Post ICG Infusion Abnormal CS ECG |
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| Mean ICG Concentrations at 120 mins |
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| Mean ICG Concentrations at 150 mins |
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| Mean ICG Concentration at 240 mins |
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| Mean ICG Concentrations at 48 hours |
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| Mean ICG Concentrations at 120 mins |
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| Mean ICG Concentrations at 150 mins |
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| Mean ICG Concentrations at 240 minutes |
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| Mean ICG Concentrations at 48 hours |
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| Percentage change in (NIR-L) absorbance at 120 minutes |
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| Percentage change in (NIR-L) absorbance at 150 minutes |
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| Percentage change in (NIR-L) absorbance at 240 minutes |
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| Percentage change in (NIR-L) absorbance at 48 hours |
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| Percentage change in (NIR-L) absorbance at 120 minutes |
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| Percentage change in (NIR-L) absorbance at 150 minutes |
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| Percentage change in (NIR-L) absorbance at 240 minutes |
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| Percentage change in (NIR-L) absorbance at 48 hours |
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