Intranasal Insulin for the Treatment of HAND
NCT03081117, Phase 1, Phase 2, Terminated, Johns Hopkins University; results first posted 2021-07-07
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intranasal Insulin for the Treatment of HAND | ClinicalTrials.gov |
| NCT number | NCT03081117 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 21 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Johns Hopkins University | ClinicalTrials.gov |
| Conditions | HIV Dementia, HIV-Associated Cognitive Motor Complex | ClinicalTrials.gov |
| Interventions | Insulin, intranasal, Placebo, intranasal | ClinicalTrials.gov |
| First posted | 2017-03-16 | ClinicalTrials.gov |
| Last updated | 2021-07-07 | ClinicalTrials.gov |
| Results first posted | 2021-07-07 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Serious Adverse Event Frequency | Total during 24-week trial | Number of documented serious adverse events per participant, mean | ClinicalTrials.gov |
| Primary | Serious Adverse Event Frequency, Participant Count | Total during 24-week trial | Number participants with at least one documented serious adverse event, count | ClinicalTrials.gov |
| Primary | Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score | Difference between baseline and week 24 visits | Change in GDS, measured at two time points, baseline and Week 24 visits. GDS is a composite score based on neurocognitive test performance. The 14 data points that comprise the GDS include Hopkins Verbal Learning Test (trials 1-3 total score and delayed recall), Rey Complex Figure Test (copy and delayed recall), WAIS symbol-digit test, grooved pegboard (dominant and non-dominant), CalCAP (Choice reaction time and Sequential reaction time), Trail-making Test (Parts A and B), Stroop Color Interference Test (trial 3), timed gait (3 trials average), and verbal fluency (FAS). Raw scores were transformed to t-scores using age/education stratified normative data, then assigned a discrete value from 0 to 5 using the following t-score categorization: \> or = 40 is '0', 35.00 to 39.99 is '1', 30.00 to 34.99 is '2', 25.00 to 29.99 is '3', 20.00 to 24.99 is '4', and \<20 is '5'. The 14 individual scores were then averaged. A higher GDS is a worse outcome (0 = no deficits and 5 = maximum deficits). | ClinicalTrials.gov |
| Secondary | Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score | Difference between baseline and week 24 visits | NPZ-8 score at 24 weeks minus baseline NPZ-8 score: The NPZ-8 is an average of 8 individual Z-scores, where higher values indicate greater neurocognitive performance (better outcome). The NPZ-8 represents the number of standard deviations an individual's performance is away from the mean (Z-score = 0) of age and education matched reference populations where performance worse than the mean had negative Z-scores (i.e. Z-scores were inverted for tests scored on speed). The NPZ-8 average is comprised of 8 data points from 6 tests: timed gait, WAIS symbol-digit, grooved pegboard dominant \& non-dominant, CalCAP Choice \& Sequential reaction times, and the Trail-making Test parts A \& B. Raw scores were transformed to Z-scores for each test and then averaged to calculate the NPZ-8 score at each visit (Z-scores +/-3.5 standard deviations from mean limited to +/-3.5). Positive change in NPZ-8 from baseline to Week 24 indicated improved performance and negative change indicated worse performance. | ClinicalTrials.gov |
| Secondary | CSF Biomarkers, Week 24 Visit Value Minus Baseline Value | Between baseline and week 24 visits | Changes in cerebrospinal fluid (CSF) concentrations of ceramide, sphingomyelin, citrate, neurofilament protein; brain-derived neurotrophic factor (BDNF), protein carbonyl, Aβ-42 | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in the basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Single voxel-magnetic resonance spectroscopy (SV-MRS) myoinositol in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Single voxel-magnetic resonance spectroscopy (SV-MRS) choline in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in basal ganglia. Results were reported as concentrations measured in approximated mmol/L (institutional units). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Single voxel-magnetic resonance spectroscopy (SV-MRS) N-acetyl aspartate concentrations in frontal white matter. Results were reported as concentrations measured in approximated mmol/L (institutional units). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Diffusion tensor imaging (DTI), change in whole brain fractional anisotropy (FA) between baseline and 24 weeks. FA is a unitless index that is used for measuring diffusion asymmetry. FA values range from 0 to 1 (0 equals no anisotropy; greater anisotropy is indicated by higher FA values approaching the maximum of 1). FA was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean FA = (Sum of (each ROI's FA \* volume)) / (Sum of all ROI volumes). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Diffusion weighted imaging, change in whole brain mean diffusivity (MD) between baseline and 24 weeks. MD was measured as the mean of three eigenvalues and has the unit m\^2/s. Higher values indicate greater diffusivity. MD was measured in regions of interest (ROI) automatically generated by the multi-atlas label-fusion method implemented in the MRICloud. Whole brain mean MD = (Sum of (each ROI's MD \* volume)) / (Sum of all ROI volumes). | ClinicalTrials.gov |
| Secondary | Neuroimaging Markers: ASL, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Arterial spin labeling (ASL), a novel measure of cerebral blood flow | ClinicalTrials.gov |
Outcomes 14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Serious Adverse Event Frequency | Total during 24-week trial | Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks.~Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention. | Number of SAEs/participant | MEAN | ClinicalTrials.gov |
| PRIMARY | Serious Adverse Event Frequency, Participant Count | Total during 24-week trial | Enrolled: All participants started on study intervention. Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks.~Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention. | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| PRIMARY | Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score | Difference between baseline and week 24 visits | Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks.~Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention. | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score | Difference between baseline and week 24 visits | Completed Trial (ITT): All participants with both primary outcome measures at 24 weeks.~Completed Trial (Per Protocol): Participants with both primary outcome measures at 24 weeks and who demonstrated greater than 16 weeks adherence to the study intervention. | z-score | MEAN | ClinicalTrials.gov |
| SECONDARY | CSF Biomarkers, Week 24 Visit Value Minus Baseline Value | Between baseline and week 24 visits | Baseline and Week 24 CSF samples were collected from only 4 participants. CSF biomarker assays were not performed because the target number of 36 evaluable patients was not reached, and we had insufficient power to detect a true difference in change per the statistical analysis plan. | ClinicalTrials.gov | ||
| SECONDARY | Neuroimaging Markers: SV-MRS, Myoinositol, Basal Ganglia, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one had invalid basal ganglia MRS results at Week 24, another is missing all Week 24 MRS results due to technical error in data collection.~Available MRS (data for outcome measure): 14 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 11 Pts. | mmol/L, approx. (institutional units) | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: SV-MRS, Myoinositol, Frontal White Matter, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, three Pts had invalid frontal white matter MRS results at either baseline or Week 24, and a fourth is missing all Week 24 MRS results due to technical error in data collection.~Available MRS (data for outcome measure): 12 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 9 Pts | mmol/L, approx. (institutional units) | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: SV-MRS, Choline, Basal Ganglia, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one had invalid basal ganglia MRS results at Week 24, another is missing all Week 24 MRS results due to technical error in data collection.~Available MRS (data for outcome measure): 14 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 11 Pts | mmol/L, approx. (institutional units) | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: SV-MRS, Choline, Frontal White Matter, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, three Pts had invalid frontal white matter MRS results at either baseline or Week 24, and a fourth is missing all Week 24 MRS results due to technical error in data collection.~Available MRS (data for outcome measure): 12 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 9 Pts | mmol/L, approx. (institutional units) | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Basal Ganglia, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one had invalid basal ganglia MRS results at Week 24, another is missing all Week 24 MRS results due to technical error in data collection.~Available MRS (data for outcome measure): 14 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 11 Pts | mmol/L, approx. (institutional units) | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: SV-MRS, N-acetyl Aspartate, Frontal White Matter, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, three Pts had invalid frontal white matter MRS results at either baseline or Week 24, and a fourth is missing all Week 24 MRS results due to technical error in data collection.~Available MRS (data for outcome measure): 12 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 9 Pts | mmol/L, approx. (institutional units) | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: DTI, Whole Brain Mean Fractional Anisotropy (FA), Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one is missing all Week 24 DTI results due to technical error in data collection.~Available MRS (data for outcome measure): 15 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 12 Pts | index | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: Diffusion Weighted Imaging, Whole Brain Mean Diffusivity, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | MRS was performed at both baseline and 24 Weeks on 16 participants (Pts). However, one is missing all Week 24 DTI results due to technical error in data collection.~Available MRS (data for outcome measure): 15 Pts. (Note: one of the Pts did not complete trial, two were Intent-to-Treat) Completed Trial (Per Protocol) with available MRS data: 12 Pts | m^2/s | MEAN | ClinicalTrials.gov |
| SECONDARY | Neuroimaging Markers: ASL, Week 24 Visit Value Minus Baseline Value | Changes between baseline and week 24 visits | Collected data were not considered valid due to an equipment malfunction. | ClinicalTrials.gov |
Results by group 52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Serious Adverse Event Frequency | Insulin, Intranasal | Enrolled | 0.30 | Standard Deviation 0.67 | Number of SAEs/participant | ClinicalTrials.gov |
| Serious Adverse Event Frequency | Placebo, Intranasal | Enrolled | 0.18 | Standard Deviation 0.40 | Number of SAEs/participant | ClinicalTrials.gov |
| Serious Adverse Event Frequency | Insulin, Intranasal | Completed Trial (ITT) | 0.14 | Standard Deviation 0.38 | Number of SAEs/participant | ClinicalTrials.gov |
| Serious Adverse Event Frequency | Placebo, Intranasal | Completed Trial (ITT) | 0.22 | Standard Deviation 0.44 | Number of SAEs/participant | ClinicalTrials.gov |
| Serious Adverse Event Frequency | Insulin, Intranasal | Completed Trial (Per Protocol) | 0.00 | Standard Deviation 0.00 | Number of SAEs/participant | ClinicalTrials.gov |
| Serious Adverse Event Frequency | Placebo, Intranasal | Completed Trial (Per Protocol) | 0.25 | Standard Deviation 0.46 | Number of SAEs/participant | ClinicalTrials.gov |
| Serious Adverse Event Frequency, Participant Count | Insulin, Intranasal | Enrolled | 2 | Participants | ClinicalTrials.gov | |
| Serious Adverse Event Frequency, Participant Count | Placebo, Intranasal | Enrolled | 2 | Participants | ClinicalTrials.gov | |
| Serious Adverse Event Frequency, Participant Count | Insulin, Intranasal | Completed Trial (ITT) | 1 | Participants | ClinicalTrials.gov | |
| Serious Adverse Event Frequency, Participant Count | Placebo, Intranasal | Completed Trial (ITT) | 2 | Participants | ClinicalTrials.gov | |
| Serious Adverse Event Frequency, Participant Count | Insulin, Intranasal | Completed Trial (Per Protocol) | 0 | Participants | ClinicalTrials.gov | |
| Serious Adverse Event Frequency, Participant Count | Placebo, Intranasal | Completed Trial (Per Protocol) | 2 | Participants | ClinicalTrials.gov | |
| Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score | Insulin, Intranasal | Completed Trial (ITT) | -0.1614 | Standard Deviation 0.3810 | units on a scale | ClinicalTrials.gov |
| Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score | Placebo, Intranasal | Completed Trial (ITT) | 0.2300 | Standard Deviation 0.2981 | units on a scale | ClinicalTrials.gov |
| Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score | Insulin, Intranasal | Completed Trial (Per Protocol) | -0.2383 | Standard Deviation 0.3529 | units on a scale | ClinicalTrials.gov |
| Neurocognitive Performance: Global Deficit Score (GDS), Week 24 Visit Score Minus Baseline Score | Placebo, Intranasal | Completed Trial (Per Protocol) | 0.2763 | Standard Deviation 0.2820 | units on a scale | ClinicalTrials.gov |
| Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score | Insulin, Intranasal | Completed Trial (ITT) | -0.09 | Standard Deviation 0.39 | z-score | ClinicalTrials.gov |
| Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score | Placebo, Intranasal | Completed Trial (ITT) | -0.01 | Standard Deviation 0.57 | z-score | ClinicalTrials.gov |
| Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score | Insulin, Intranasal | Completed Trial (Per Protocol) | -0.07 | Standard Deviation 0.42 | z-score | ClinicalTrials.gov |
| Neurocognitive Performance: NPZ-8 Score, Week 24 Visit Score Minus Baseline Score | Placebo, Intranasal | Completed Trial (Per Protocol) | -0.02 | Standard Deviation 0.60 | z-score | ClinicalTrials.gov |
Participant flow 12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Insulin, Intranasal | 10 | ClinicalTrials.gov | |
| Overall Study | STARTED | Placebo, Intranasal | 11 | ClinicalTrials.gov | |
| Overall Study | Primary Outcome 1 (SAE) | Insulin, Intranasal | 10 | ClinicalTrials.gov | |
| Overall Study | Primary Outcome 1 (SAE) | Placebo, Intranasal | 11 | ClinicalTrials.gov | |
| Overall Study | Secondary Measures Collected at Week 24 | Insulin, Intranasal | 8 | ClinicalTrials.gov | |
| Overall Study | Secondary Measures Collected at Week 24 | Placebo, Intranasal | 9 | ClinicalTrials.gov | |
| Overall Study | Completed (ITT): Primary Outcome 2 (GDS) | Insulin, Intranasal | 7 | ClinicalTrials.gov | |
| Overall Study | Completed (ITT): Primary Outcome 2 (GDS) | Placebo, Intranasal | 9 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Insulin, Intranasal | 6 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Placebo, Intranasal | 8 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Insulin, Intranasal | 4 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Placebo, Intranasal | 3 | ClinicalTrials.gov |
Adverse events 46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Fall | General disorders | Insulin, Intranasal | 1 | 10 | 1 | ClinicalTrials.gov |
| other | Fall | General disorders | Placebo, Intranasal | 2 | 11 | 2 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Insulin, Intranasal | 3 | 10 | 3 | ClinicalTrials.gov |
| other | Headache | Nervous system disorders | Placebo, Intranasal | 5 | 11 | 5 | ClinicalTrials.gov |
| other | Nosebleed | General disorders | Insulin, Intranasal | 1 | 10 | 1 | ClinicalTrials.gov |
| other | Nosebleed | General disorders | Placebo, Intranasal | 2 | 11 | 2 | ClinicalTrials.gov |
| other | Rash | Skin and subcutaneous tissue disorders | Insulin, Intranasal | 3 | 10 | 3 | ClinicalTrials.gov |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo, Intranasal | 1 | 11 | 1 | ClinicalTrials.gov |
| other | Congestion/Runny Nose | General disorders | Insulin, Intranasal | 4 | 10 | 4 | ClinicalTrials.gov |
| other | Congestion/Runny Nose | General disorders | Placebo, Intranasal | 3 | 11 | 3 | ClinicalTrials.gov |
| other | Nasal Irritation or Reaction (during administration of investigational product) | General disorders | Insulin, Intranasal | 7 | 10 | 7 | ClinicalTrials.gov |
| other | Nasal Irritation or Reaction (during administration of investigational product) | General disorders | Placebo, Intranasal | 4 | 11 | 4 | ClinicalTrials.gov |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Insulin, Intranasal | 2 | 10 | 2 | ClinicalTrials.gov |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Placebo, Intranasal | 5 | 11 | 5 | ClinicalTrials.gov |
| other | Odor/Taste (during administration of investigational product) | Product Issues | Insulin, Intranasal | 5 | 10 | 5 | ClinicalTrials.gov |
| other | Odor/Taste (during administration of investigational product) | Product Issues | Placebo, Intranasal | 1 | 11 | 1 | ClinicalTrials.gov |
| other | Accidental Injury | Injury, poisoning and procedural complications | Insulin, Intranasal | 2 | 10 | 2 | ClinicalTrials.gov |
| other | Accidental Injury | Injury, poisoning and procedural complications | Placebo, Intranasal | 1 | 11 | 1 | ClinicalTrials.gov |
| other | Diarrhea | Gastrointestinal disorders | Insulin, Intranasal | 0 | 10 | 0 | ClinicalTrials.gov |
| other | Diarrhea | Gastrointestinal disorders | Placebo, Intranasal | 3 | 11 | 3 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Insulin, Intranasal | 0 | 10 | ClinicalTrials.gov |
| Total, all-cause mortality | Placebo, Intranasal | 0 | 11 | ClinicalTrials.gov |
| Total, other adverse events | Insulin, Intranasal | 10 | 10 | ClinicalTrials.gov |
| Total, other adverse events | Placebo, Intranasal | 11 | 11 | ClinicalTrials.gov |
| Total, serious adverse events | Insulin, Intranasal | 2 | 10 | ClinicalTrials.gov |
| Total, serious adverse events | Placebo, Intranasal | 2 | 11 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Insulin, Intranasal vs Placebo, Intranasal: deaths from any cause | Trial comparisons |
| Insulin, Intranasal vs Placebo, Intranasal: serious adverse events | Trial comparisons |
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Choice Reaction Time | Primary outcome | ConductCognition |
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Coding | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)