Memory and Insulin in Early Alzheimer's Disease
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Intranasal Insulin and Memory in Early Alzheimer's Disease
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
July 14, 2015
CompletedJuly 14, 2015
July 1, 2015
4.6 years
December 19, 2007
January 9, 2014
July 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
fMRI Measure of Hippocampal Activation
Percentage active voxels of total hippocampal volume of interest
30 minutes After Intervention Administration
Secondary Outcomes (1)
Global Cognition
90 mins
Study Arms (2)
Intranasal Insulin Aspart
EXPERIMENTALParticipants 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.
Intranasal Saline (placebo)
ACTIVE COMPARATORParticipants 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.
Interventions
40IU insulin aspart applied intranasally
Eligibility Criteria
You may qualify if:
- Patients with Early Alzheimer's disease
You may not qualify if:
- Patients with Late Alzheimer's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jeff Burns, MDlead
Study Sites (1)
University of Kansas Medical Center, Hoglund Brain Imaging Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jeffrey Burns
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey M Burns, MD
University of Kansas Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Associate Director University of Kansas Alzheimer's Disease Center
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 28, 2007
Study Start
October 1, 2007
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
July 14, 2015
Results First Posted
July 14, 2015
Record last verified: 2015-07