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The proposed pilot study will provide safety and efficacy preliminary data regarding singular and combined effects of two therapeutic approaches, intranasal insulin and treatment with the sodium-glucose cotransporter type 2 inhibitor (SGLT2i) empagliflozin, to correct bioenergetic and vascular dysfunction in adults with preclinical Alzheimer's disease (AD) and amnestic mild cognitive impairment (aMCI) or early AD.
The study will consist of a single site, randomized, double-blind trial comparing the effects of 4 weeks of intranasal insulin(40 International Units four times daily), empagliflozin (10 mg daily) and combined intranasal insulin (INI) and empagliflozin (empa) compared with placebo on cerebrospinal fluid (CSF) biomarkers and cognition.
At study entry, participants will be randomized to one of 4 conditions: INI, empa, INI+empa or placebo. Participants who are cognitively normal but have abnormal elevations of brain amyloid or who have mild cognitive impairment (MCI) or early Alzheimer's disease (AD) will be enrolled.
The primary outcome measure will consist of safety (treatment-related serious adverse events). Secondary outcome measures will consist of cerebrospinal fluid (CSF) biomarkers, cognition, and cerebral blood flow.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Insulin and Empagliflozin Placebo | Experimental |
|
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| Empagliflozin and Intranasal Insulin Placebo | Experimental |
|
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| Intranasal Insulin and Empagliflozin | Experimental |
|
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| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin (Humulin® R U-100) | Drug | Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Serious Adverse Events as Assessed by CTCAE v5.0 | Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v5.0). The number of participants with grade 3 or greater adverse events that were deemed to be possibly, probably, or definitely related to study treatment will be reported. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Preclinical Alzheimer Cognitive Composite V5 (PACC5) Z-Score | Cognition will be measured using the Preclinical Alzheimer Cognitive Composite V5 (PACC5) scale, which includes the free/cued selective reminding test, delayed paragraph recall, digit-symbol substitution, mini mental state score, and the category fluency task. The PACC5 is a composite score comprised of measures of global cognition, memory, and executive function. A z-score of 0 equals the mean for the baseline PACC5 score for all analyzed participants. Higher (more positive) z-scores mean greater improvement in the cognition test over time. There are no clinically relevant thresholds as this is a cognitive variable. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Craft, PhD | Wake Forest University Health Sciences / Wake Forest School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences / Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21514249 | Background | Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21. | |
| 3758265 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Insulin and Empagliflozin Placebo |
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. |
| FG001 | Empagliflozin and Intranasal Insulin Placebo |
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. |
| FG002 | Intranasal Insulin and Empagliflozin |
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. |
| FG003 | Placebo |
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Insulin and Empagliflozin Placebo |
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. |
| 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 | Number of Participants With Treatment-Related Serious Adverse Events as Assessed by CTCAE v5.0 | Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE v5.0). The number of participants with grade 3 or greater adverse events that were deemed to be possibly, probably, or definitely related to study treatment will be reported. | One participant in Insulin/Empagliflozin Placebo arm withdrew before starting study drug | Posted | Number | participants | Week 8 |
|
baseline through week 8
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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 | Intranasal Insulin and Empagliflozin Placebo |
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Craft, PhD | Atrium Health Wake Forest Baptist | 336.713.8846 | Suzanne.Craft@advocatehealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2023 | Sep 8, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2024 | Oct 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| C570240 | empagliflozin |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Neither participants nor site personnel involved in assessing participants will know which dose of insulin is being administered. Exceptions will be the study nurse who is directly involved in preparing the insulin.
|
| Empagliflozin 10 MG | Drug | Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. |
|
| Aptar Pharma CPS Intranasal Delivery Device | Device | Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. |
|
| Placebo (Insulin Diluent) | Drug | Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. |
|
| Placebo (Capsules) | Drug | Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. |
|
| Baseline to Week 4 |
| Change in the 14-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score | A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 65 (worse), and are added to the mean of the words not immediately recalled (max of 10) and the number of items not recalled after a delay (ranging from 0-10) all total the maximum score of 90. A positive change indicates cognitive worsening. | Baseline to Week 4 |
| Change in Amyloid β-peptide (Aβ) 40 (Aβ40) in Cerebrospinal Fluid (CSF) | Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 40. CSF Aβ40 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain. | Baseline to Week 4 |
| Change in Amyloid β-peptide (Aβ) 42 (Aβ42) in Cerebrospinal Fluid (CSF) | Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 42. CSF Aβ42 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain. | Baseline to Week 4 |
| Change in Cerebrospinal Fluid (CSF) Levels of Total Tau | Cerebrospinal fluid (CSF) samples will be used to measure the levels of total tau protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker. | Baseline to Week 4 |
| Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181 | Cerebrospinal fluid (CSF) samples will be used to measure the levels of phospho-tau 181 protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker. | Baseline to Week 4 |
| Change in Total Cerebral Blood Flow (CBF) Using MRI Pseudocontinuous Arterial Spin Labeling (ASL) | Change in CBF in mL/100g/min, calculated as the difference between the pre- and post ASL flow in response to the study intervention. | Baseline to Week 4 |
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| 16717171 | Background | Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. |
| 41057918 | Derived | Erichsen JM, Register TC, Sutphen C, Ma D, Gaussoin SA, Rudolph M, Rundle M, Bateman JT, Lockhart SN, Sai KKS, Whitlow C, Craft S. A phase 2A/B randomized trial of metabolic modulators intranasal insulin and empagliflozin for MCI and early AD. Alzheimers Dement. 2025 Oct;21(10):e70704. doi: 10.1002/alz.70704. |
| BG001 | Empagliflozin and Intranasal Insulin Placebo |
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. |
| BG002 | Intranasal Insulin and Empagliflozin |
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. |
| BG003 | Placebo |
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Empagliflozin and Intranasal Insulin Placebo |
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. |
| OG002 | Intranasal Insulin and Empagliflozin |
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. |
| OG003 | Placebo |
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. |
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| Secondary | Change in the Preclinical Alzheimer Cognitive Composite V5 (PACC5) Z-Score | Cognition will be measured using the Preclinical Alzheimer Cognitive Composite V5 (PACC5) scale, which includes the free/cued selective reminding test, delayed paragraph recall, digit-symbol substitution, mini mental state score, and the category fluency task. The PACC5 is a composite score comprised of measures of global cognition, memory, and executive function. A z-score of 0 equals the mean for the baseline PACC5 score for all analyzed participants. Higher (more positive) z-scores mean greater improvement in the cognition test over time. There are no clinically relevant thresholds as this is a cognitive variable. | Insulin/Empagliflozin Placebo Arm: 1 participant in withdrew prior to receiving study drug, 3 participants did not complete study, 1 participant did not have data for this outcome. Placebo Arm: one participant did not complete study, 1 participant did not have data for this outcome. | Posted | Mean | Standard Deviation | z-score | Baseline to Week 4 |
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| Secondary | Change in the 14-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) Score | A psychometric instrument that evaluates memory, attention, reasoning, language, orientation, and praxis. A higher score indicates more impairment. Scores from the original portion of the test range from 0 (best) to 65 (worse), and are added to the mean of the words not immediately recalled (max of 10) and the number of items not recalled after a delay (ranging from 0-10) all total the maximum score of 90. A positive change indicates cognitive worsening. | Insulin/Empagliflozin Placebo Arm: 1 participant in withdrew prior to receiving study drug, 3 participants did not complete study, 1 participant did not have data for this outcome. Placebo Arm: one participant did not complete study, 1 participant did not have data for this outcome. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Week 4 |
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| Secondary | Change in Amyloid β-peptide (Aβ) 40 (Aβ40) in Cerebrospinal Fluid (CSF) | Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 40. CSF Aβ40 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain. | Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study. | Posted | Mean | Standard Deviation | pg/ml | Baseline to Week 4 |
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| Secondary | Change in Amyloid β-peptide (Aβ) 42 (Aβ42) in Cerebrospinal Fluid (CSF) | Cerebrospinal fluid (CSF) samples will be used to measure the levels of amyloid β-peptide (Aβ) 42. CSF Aβ42 is a key Alzheimer's disease (AD) biomarker that reflects pathological aggregation of amyloid in the brain. | Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study. | Posted | Mean | Standard Deviation | pg/ml | Baseline to Week 4 |
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| Secondary | Change in Cerebrospinal Fluid (CSF) Levels of Total Tau | Cerebrospinal fluid (CSF) samples will be used to measure the levels of total tau protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker. | Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study. | Posted | Mean | Standard Deviation | pg/ml | Baseline to Week 4 |
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| Secondary | Change in Cerebrospinal Fluid (CSF) Levels of Phospho-Tau 181 | Cerebrospinal fluid (CSF) samples will be used to measure the levels of phospho-tau 181 protein in the brain to assess impact on brain tau as a relevant Alzheimer's Disease (AD) biomarker. | Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study. Insulin/Empagliflozin Arm: 3 participants did not complete the post-treatment lumbar puncture. Placebo Arm: 1 participant did not finish the study. | Posted | Mean | Standard Deviation | pg/ml | Baseline to Week 4 |
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| Secondary | Change in Total Cerebral Blood Flow (CBF) Using MRI Pseudocontinuous Arterial Spin Labeling (ASL) | Change in CBF in mL/100g/min, calculated as the difference between the pre- and post ASL flow in response to the study intervention. | Insulin/Empagliflozin Placebo Arm: 1 participant withdraw before starting study drug, 3 participants did not finish the study, 1 participant missing data for this outcome. Empagliflozin/ Insulin Placebo Arm: 1 participant missing data for this outcome. Insulin/Empagliflozin Arm: 1 participant missing data for this outcome. Placebo Arm: 1 participant did not finish the study, 1 participant missing data for this outcome. | Posted | Mean | Standard Deviation | mL/100g/min | Baseline to Week 4 |
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| 0 |
| 14 |
| 0 |
| 14 |
| 8 |
| 14 |
| EG001 | Empagliflozin and Intranasal Insulin Placebo |
Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. | 0 | 12 | 0 | 12 | 8 | 12 |
| EG002 | Intranasal Insulin and Empagliflozin |
Insulin (Humulin® R U-100): Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. Empagliflozin 10 MG: Participants will be assigned to receive Empagliflozin 10 mg capsules to be taken by mouth once daily. Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. | 0 | 11 | 0 | 11 | 6 | 11 |
| EG003 | Placebo |
Aptar Pharma CPS Intranasal Delivery Device: Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. Placebo (Insulin Diluent): Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. Placebo (Capsules): Participants will be assigned to receive placebo capsules (Empagliflozin 10 mg) to be taken by mouth once daily. | 0 | 10 | 0 | 10 | 6 | 10 |
| nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| constipation | Gastrointestinal disorders | Systematic Assessment |
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| abdominal hernia | Gastrointestinal disorders | Systematic Assessment |
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| head congestion | General disorders | Systematic Assessment |
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| back pain after lumbar puncture | General disorders | Systematic Assessment |
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| dizziness | General disorders | Systematic Assessment |
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| chronic retinal detachment | Eye disorders | Systematic Assessment |
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| toothache/extraction | General disorders | Systematic Assessment |
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| hot flashes | General disorders | Systematic Assessment |
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| pain at glucose monitor site | General disorders | Systematic Assessment |
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| fall | General disorders | Systematic Assessment |
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| confusion | General disorders | Systematic Assessment |
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| nerve pain during lumbar puncture | General disorders | Systematic Assessment |
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| musculoskeletal pain | General disorders | Systematic Assessment |
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| increased urination | General disorders | Systematic Assessment |
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| increased appetite | General disorders | Systematic Assessment |
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| nasal stinging | General disorders | Systematic Assessment |
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| vaginal yeast infection | Infections and infestations | Systematic Assessment |
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| hoarseness/sore throat | General disorders | Systematic Assessment |
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| hypotension | General disorders | Systematic Assessment |
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| urinary tract infection | Infections and infestations | Systematic Assessment |
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| syncopal episode during lumbar puncture | General disorders | Systematic Assessment |
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| tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| lethargy | General disorders | Systematic Assessment |
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| COVID19 | Infections and infestations | Systematic Assessment |
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| upper respiratory infection | Infections and infestations | Systematic Assessment |
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| plantar fasciitis surgery | General disorders | Systematic Assessment |
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Not provided
Not provided
Not provided
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |