Trial Outcomes & Findings for SNIFF Multi-Device Study 2 (NCT NCT04199767)
NCT ID: NCT04199767
Last Updated: 2026-04-02
Results Overview
Change in cerebrospinal fluid insulin levels after receiving a 20 or 40 International Unit dose of insulin delivered with one of three devices
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline to 30 minutes after intervention administration
Results posted on
2026-04-02
Participant Flow
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms.
Participant milestones
| Measure |
CPS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
CPS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
4
|
3
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
CPS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
CPS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
SNIFF Multi-Device Study 2
Baseline characteristics by cohort
| Measure |
CPS Device: 20 IU Insulin First, Then 40 IU Insulin
n=4 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
CPS Device: 40 IU Insulin First, Then 20 IU Insulin
n=4 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 20 IU Insulin First, Then 40 IU Insulin
n=3 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 40 IU Insulin First, Then 20 IU Insulin
n=2 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63.8 years
n=5 Participants
|
70.4 years
n=5 Participants
|
83.3 years
n=10 Participants
|
73 years
n=5 Participants
|
—
|
—
|
72.6 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
—
|
—
|
9 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=5 Participants
|
—
|
—
|
4 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
13 Participants
n=48 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
—
|
—
|
13 Participants
n=48 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=48 Participants
|
|
Education
|
17.9 years
n=5 Participants
|
14.4 years
n=5 Participants
|
16.3 years
n=10 Participants
|
12.5 years
n=5 Participants
|
—
|
—
|
15 years
n=48 Participants
|
|
Mini-mental state exam
|
29.0 units on a scale
n=5 Participants
|
27.5 units on a scale
n=5 Participants
|
28.3 units on a scale
n=10 Participants
|
26 units on a scale
n=5 Participants
|
—
|
—
|
27.9 units on a scale
n=48 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 minutes after intervention administrationPopulation: 3 CPS Device 20IU/40 subjects did not complete study. Sequence of insulin dose is critical component of study. Order was counterbalanced to address a phenomenon known as Practice Effect when giving the AVLT. When memory test are given a 2nd time scores are higher because subjects have previous exposure to memory stimuli. Thus if 20IU is always given first and 40IU second, it may appear memory scores have improved due to the dose insulin when the improvement is due instead to Practice Effects.
Change in cerebrospinal fluid insulin levels after receiving a 20 or 40 International Unit dose of insulin delivered with one of three devices
Outcome measures
| Measure |
CPS Device: 20 IU Insulin First, Then 40 IU Insulin
n=1 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
CPS Device: 40 IU Insulin First, Then 20 IU Insulin
n=4 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 20 IU Insulin First, Then 40 IU Insulin
n=3 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 40 IU Insulin First, Then 20 IU Insulin
n=2 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
|---|---|---|---|---|---|---|
|
Cerebrospinal Fluid Insulin Levels
40 IU Insulin
|
0.33 micro units/mL
Interval 0.33 to 0.33
|
0.07 micro units/mL
Interval 0.002 to 0.17
|
0.17 micro units/mL
Interval 0.05 to 0.31
|
1.05 micro units/mL
Interval 0.81 to 1.28
|
—
|
—
|
|
Cerebrospinal Fluid Insulin Levels
20 IU Insulin
|
0.11 micro units/mL
Interval 0.11 to 0.11
|
0.15 micro units/mL
Interval 0.07 to 0.21
|
0.14 micro units/mL
Interval 0.01 to 0.31
|
0.26 micro units/mL
Interval 0.26 to 0.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Post lumbar puncturePopulation: 3 CPS Device 20IU/40 subjects did not complete study. Sequence of insulin dose is critical component of study. Order was counterbalanced to address a phenomenon known as Practice Effect when giving the AVLT. When memory test are given a 2nd time scores are higher because subjects have previous exposure to memory stimuli. Thus if 20IU is always given first and 40IU second, it may appear memory scores have improved due to the dose insulin when the improvement is due instead to Practice Effects.
Memory performance measured with Auditory Verbal Learning Test after administration of 20 or 40 IU insulin. Memory measure in which participant hears a list of 12 words and is asked to recall them immediately after hearing them. Total possible score is 12 for delayed recall with higher number of words being better.
Outcome measures
| Measure |
CPS Device: 20 IU Insulin First, Then 40 IU Insulin
n=1 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
CPS Device: 40 IU Insulin First, Then 20 IU Insulin
n=4 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 20 IU Insulin First, Then 40 IU Insulin
n=3 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 40 IU Insulin First, Then 20 IU Insulin
n=2 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
|---|---|---|---|---|---|---|
|
Auditory-Verbal Learning Test
20 IU Insulin
|
7 average words recalled
Interval 7.0 to 7.0
|
7.5 average words recalled
Interval 5.0 to 11.0
|
6.0 average words recalled
Interval 4.0 to 7.0
|
9.5 average words recalled
Interval 7.0 to 12.0
|
—
|
—
|
|
Auditory-Verbal Learning Test
40 IU Insulin
|
9 average words recalled
Interval 9.0 to 9.0
|
6.5 average words recalled
Interval 3.0 to 12.0
|
4.7 average words recalled
Interval 1.0 to 7.0
|
9.5 average words recalled
Interval 6.0 to 13.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 minutes after intervention administrationPopulation: 3 CPS Device 20IU/40 subjects did not complete study. Sequence of insulin dose is critical component of study. Order was counterbalanced to address a phenomenon known as Practice Effect when giving the AVLT. When memory test are given a 2nd time scores are higher because subjects have previous exposure to memory stimuli. Thus if 20IU is always given first and 40IU second, it may appear memory scores have improved due to the dose insulin when the improvement is due instead to Practice Effects.
Cerebrospinal fluid levels of the 42 amino acid isoform of the beta amyloid peptide
Outcome measures
| Measure |
CPS Device: 20 IU Insulin First, Then 40 IU Insulin
n=1 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
CPS Device: 40 IU Insulin First, Then 20 IU Insulin
n=4 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 20 IU Insulin First, Then 40 IU Insulin
n=3 Participants
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
VP7 Device: 40 IU Insulin First, Then 20 IU Insulin
n=2 Participants
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 20 IU Insulin First, Then 40 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.
20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
|
UDS Device: 40 IU Insulin First, Then 20 IU Insulin
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly \& Company): Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
|
|---|---|---|---|---|---|---|
|
Cerebrospinal Fluid Levels of AB42
20 IU Insulin
|
817 picograms/mL
Interval 817.0 to 817.0
|
1112.8 picograms/mL
Interval 833.0 to 1568.0
|
739 picograms/mL
Interval 658.0 to 884.0
|
984.5 picograms/mL
Interval 836.0 to 1133.0
|
—
|
—
|
|
Cerebrospinal Fluid Levels of AB42
40 IU Insulin
|
857 picograms/mL
Interval 857.0 to 857.0
|
910.8 picograms/mL
Interval 709.0 to 1159.0
|
840 picograms/mL
Interval 770.0 to 944.0
|
1188 picograms/mL
Interval 897.0 to 1479.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 30 minutes after intervention administrationChange in cerebrospinal fluid levels of the tau protein
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 30 minutes after intervention administrationChange in cerebrospinal fluid levels of the tau phosphorylated at isotope 181
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 30 minutes after intervention administrationChange in cerebrospinal fluid levels of the 40 amino acid isoform of the beta amyloid peptide
Outcome measures
Outcome data not reported
Adverse Events
CPS Device 20 IU Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CPS Device 40 IU Insulin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VP7 Device 20 IU Insulin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VP7 Device 40 IU Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UDS Device 20 IU Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
UDS Device 40 IU Insulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPS Device 20 IU Insulin
n=8 participants at risk
Participants in the CPS Device arm will receive regular insulin (U100, 20 IU)
|
CPS Device 40 IU Insulin
n=8 participants at risk
Participants in CPS Device arm will receive regular insulin (U100, 40 IU)
|
VP7 Device 20 IU Insulin
n=5 participants at risk
Participants in the VP7 Device arm will receive regular insulin (U100, 20 IU)
|
VP7 Device 40 IU Insulin
n=5 participants at risk
Participants in VP7 Device arm will receive regular insulin (U100, 40 IU)
|
UDS Device 20 IU Insulin
Participants in the UDS Device arm will receive regular insulin (U100, 20 IU)
|
UDS Device 40 IU Insulin
Participants in UDS Device arm will receive regular insulin (U100, 40 IU)
|
|---|---|---|---|---|---|---|
|
General disorders
leg pain
|
0.00%
0/8 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
0.00%
0/8 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
20.0%
1/5 • Number of events 1 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
0.00%
0/5 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
—
0/0 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
—
0/0 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
|
General disorders
vasovagal episode
|
0.00%
0/8 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
12.5%
1/8 • Number of events 1 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
0.00%
0/5 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
0.00%
0/5 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
—
0/0 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
—
0/0 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
|
General disorders
vomiting
|
0.00%
0/8 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
12.5%
1/8 • Number of events 1 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
0.00%
0/5 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
0.00%
0/5 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
—
0/0 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
—
0/0 • up to 6 weeks
This feasibility study was initiated with the CPS and VP7 devices. Plans to test UDS device were discontinued. No participants were assigned to the UDS device arms. Arms were not provided separately for each intervention because the sequence of insulin dose is a critical component of the study to address potential practice effects for the Auditory-Verbal Learning Test (AVLT).
|
Additional Information
Suzanne Craft, PhD
Wake Forest University School of Medicine
Phone: 336.716.8832
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place