Trial Outcomes & Findings for Memory and Insulin in Early Alzheimer's Disease (NCT NCT00581867)

Results Overview

Percentage active voxels of total hippocampal volume of interest

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

31 participants

Primary outcome timeframe

30 minutes After Intervention Administration

Results posted on

2015-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo First, Then Intranasal Insulin Participants in this group were randomized to receive placebo at the first fMRI visit and then received Intranasal Insulin at the second fMRI visit.	Intranasal Insulin First, Then Placebo Participants in this group were randomized to receive Intranasal Insulin at the first fMRI visit and then received Placebo at the second fMRI visit.
First Intervention STARTED	16	15
First Intervention COMPLETED	16	15
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	15	14
Second Intervention COMPLETED	15	14
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Memory and Insulin in Early Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=31 Participants Includes groups randomized to receive placebo first and insulin first.
Age, Continuous	72.9 years STANDARD_DEVIATION 7.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 minutes After Intervention Administration

Percentage active voxels of total hippocampal volume of interest

Outcome measures

Outcome measures
Measure	Intranasal Insulin Aspart n=29 Participants	Placebo n=29 Participants
fMRI Measure of Hippocampal Activation	36.4 percentage of active voxels Standard Deviation 31.4	41.3 percentage of active voxels Standard Deviation 33.5

SECONDARY outcome

Timeframe: 90 mins

Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale \[WMS\]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale \[WAIS\] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination \[MMSE\]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.

Outcome measures

Outcome measures
Measure	Intranasal Insulin Aspart n=29 Participants	Placebo n=29 Participants
Global Cognition	-.05 z-scores Standard Deviation 1.15	-.02 z-scores Standard Deviation 1.11

Adverse Events

Intranasal Insulin Aspart

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Intranasal Insulin Aspart n=29 participants at risk Intranasal Insulin was administered in either first or second intervention period.	Placebo n=29 participants at risk Placebo was administered in either first or second intervention period.
Respiratory, thoracic and mediastinal disorders Death	0.00% 0/29	3.4% 1/29 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Burns

University of Kansas Medical Center

Phone: (913) 588-0555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place