Trial Outcomes & Findings for Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients. (NCT NCT01436045)

Last Updated: 2015-10-19

Results Overview

The results are presented as a mean number of correct responses for each cognitive assessment. For each of these, a lower number correct is indicative of a higher cognitive deficit. Ranges are as follows: RBANS List Learning (0-40), RBANS Story Memory (0-24), RBANS Figure Copy (0-20), RBANSLine Orientation (0-20), RBANS Semantic Fluency (0-unlimited), RBANS List Recall (0-10), RBANS List Recognition (0-20), RBANS Story Recall (0-12), RBANS Figure Recall (0-20), Digit Span Forward (0-16), Digit Span Backward (0-16), Boston Naming (0-15).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

20 minutes post-intranasal administration

Results posted on

2015-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Insulin Glulisine, Then Placebo A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits. Insulin glulisine (5 minutes), Washout (1 week), Placebo (5 minutes) Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril) Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)	Placebo, Then Insulin Glulisine A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits. Placebo (5 minutes), Washout (1 week), Insulin Glulisine (5 minutes) Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril) Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Partipants n=12 Participants Participants who received either intranasal glulisine (0.10 milliliter (mL) in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
Age, Continuous	72 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Mini Mental State Examination (MMSE)	22.17 units on a scale STANDARD_DEVIATION 2.62 • n=5 Participants
University of Pennsylvania Smell Inventory Test (UPSIT)	11.8 units on a scale STANDARD_DEVIATION 2.52 • n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes post-intranasal administration

Outcome measures

Outcome measures
Measure	Post-Insulin Glulisine n=12 Participants Results of cognitive assessment after intranasal treatment with Insulin Glulisine.	Post-Placebo n=12 Participants Results of cognitive assessment after intranasal treatment with Placebo.
Cognitive Performance RBANS List Learning	15.92 mean total correct responses Standard Error 1.32	16.67 mean total correct responses Standard Error 2.02
Cognitive Performance RBANS Story Memory	8.58 mean total correct responses Standard Error 1.17	8.41 mean total correct responses Standard Error 1.55
Cognitive Performance RBANS Figure Copy	16.58 mean total correct responses Standard Error 0.98	16.92 mean total correct responses Standard Error 3.42
Cognitive Performance RBANS Line Orientation	14.25 mean total correct responses Standard Error 0.97	12.25 mean total correct responses Standard Error 1.38
Cognitive Performance RBANS Semantic Fluency	12.25 mean total correct responses Standard Error 1.38	12.5 mean total correct responses Standard Error 1.75
Cognitive Performance RBANS List Recall	0.83 mean total correct responses Standard Error 0.42	1.0 mean total correct responses Standard Error 0.51
Cognitive Performance RBANS List Recognition	14.92 mean total correct responses Standard Error 0.69	14.75 mean total correct responses Standard Error 0.97
Cognitive Performance RBANS Story Recall	2.12 mean total correct responses Standard Error 0.96	2.33 mean total correct responses Standard Error 0.90
Cognitive Performance RBANS Figure Recall	4.83 mean total correct responses Standard Error 1.84	4.92 mean total correct responses Standard Error 1.59
Cognitive Performance Digit Span Forward	9.42 mean total correct responses Standard Error 0.50	9.0 mean total correct responses Standard Error 0.44
Cognitive Performance Digit Span Backward	5.58 mean total correct responses Standard Error 0.45	5.75 mean total correct responses Standard Error 0.49
Cognitive Performance Boston Naming Test	11.75 mean total correct responses Standard Error 1.05	11.75 mean total correct responses Standard Error 1.10

PRIMARY outcome

Timeframe: 20 minutes post-intranasal administration

The results are presented as the number of seconds to complete Trails B. For each of these, a higher number of seconds is indicative of a higher cognitive deficit.

Outcome measures

Outcome measures
Measure	Post-Insulin Glulisine n=12 Participants Results of cognitive assessment after intranasal treatment with Insulin Glulisine.	Post-Placebo n=12 Participants Results of cognitive assessment after intranasal treatment with Placebo.
Trails B - Seconds	166.83 mean seconds Standard Error 20.82	177.25 mean seconds Standard Error 21.65

PRIMARY outcome

Timeframe: 20 minutes post-intranasal administration

The results are presented as the mean sum of the errors during the Trails B assessment For each of these, a higher number of errors is indicative of a higher cognitive deficit.

Outcome measures

Outcome measures
Measure	Post-Insulin Glulisine n=12 Participants Results of cognitive assessment after intranasal treatment with Insulin Glulisine.	Post-Placebo n=12 Participants Results of cognitive assessment after intranasal treatment with Placebo.
Trails B - Errors	1.17 mean number of errors Standard Error 0.27	2.08 mean number of errors Standard Error 0.31

SECONDARY outcome

Timeframe: 60 minute post intranasal administration

The Sniff Magnitude Test (SMT) measures olfactory function not influenced by cognitive problems (minimal dependence on language, cognitive ability, memory, and odor naming ability). Sniff magnitude ratios are calculated as a ratio of sniff magnitudes (area under the sniff curve). Lower sniff magnitude ratios indicate more impairment. \[average sniff magnitude of malodor/average sniff magnitude to a null odor\]

Outcome measures

Outcome measures
Measure	Post-Insulin Glulisine n=12 Participants Results of cognitive assessment after intranasal treatment with Insulin Glulisine.	Post-Placebo n=12 Participants Results of cognitive assessment after intranasal treatment with Placebo.
Olfactory Function	2.5 ratio of area under the sniff curve Standard Error 0.15	2.33 ratio of area under the sniff curve Standard Error 0.19

Adverse Events

All Study Partipants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael H Rosenbloom, MD

HealthPartners Institute for Education and Research

Phone: 6512547900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place