Memory and Insulin in Early Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: Insulin Aspart

• Registration Number: NCT00581867
• Lead Sponsor: Jeff Burns, MD

Brief Summary

To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.

Detailed Description

Functional MRI study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early Alzheimer's disease and cognitively normal older adults. The role of the apoE-e4 allele in modulating brain insulin responses is also addressed.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-28
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2014-01-09
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-10
• Last Update Submitted: 2015-07-10
• Results First Posted: 2015-07-14
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients with Early Alzheimer's disease

Exclusion Criteria

• Patients with Late Alzheimer's disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intranasal Saline (placebo)	Placebo	Participants were administered intranasal saline (placebo) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.
Intranasal Insulin Aspart	Insulin Aspart	Participants were administered intranasal insulin aspart (40 IU) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

Primary Outcome Measures

Name	Time	Method
fMRI Measure of Hippocampal Activation	30 minutes After Intervention Administration	Percentage active voxels of total hippocampal volume of interest

Secondary Outcome Measures

Name	Time	Method
Global Cognition	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.

Trial Locations

Locations (1)

University of Kansas Medical Center, Hoglund Brain Imaging Center; 🇺🇸 Kansas City, Kansas, United States