Memory and Insulin in Early Alzheimer's Disease (MAIN)

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ClinicalTrials.gov Identifier: NCT00581867

Recruitment Status : Completed

First Posted : December 28, 2007

Results First Posted : July 14, 2015

Last Update Posted : July 14, 2015

Sponsor:

Information provided by (Responsible Party):

Jeff Burns, MD, University of Kansas Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer's Disease	Drug: Insulin Aspart Drug: Placebo	Phase 1 Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	31 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Basic Science
Official Title:	Intranasal Insulin and Memory in Early Alzheimer's Disease
Study Start Date :	October 2007
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

Drug Information available for: Insulin Insulin human Insulin aspart

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intranasal 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.	Drug: Insulin Aspart 40IU insulin aspart applied intranasally Other Name: intranasal insulin
Active Comparator: Intranasal Saline (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.	Drug: Placebo Placebo Other Name: saline

Outcome Measures

Primary Outcome Measures :

fMRI Measure of Hippocampal Activation [ Time Frame: 30 minutes After Intervention Administration ]
Percentage active voxels of total hippocampal volume of interest

Secondary Outcome Measures :

Global Cognition [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with Early Alzheimer's disease

Exclusion Criteria:

Patients with Late Alzheimer's disease

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581867

Locations

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United States, Kansas
University of Kansas Medical Center, Hoglund Brain Imaging Center
Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

Jeff Burns, MD

Investigators

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Principal Investigator:	Jeffrey M Burns, MD	University of Kansas Medical Center

More Information

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Responsible Party:	Jeff Burns, MD, Professor, Associate Director University of Kansas Alzheimer's Disease Center, University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT00581867
Other Study ID Numbers:	10896
First Posted:	December 28, 2007 Key Record Dates
Results First Posted:	July 14, 2015
Last Update Posted:	July 14, 2015
Last Verified:	July 2015

Additional relevant MeSH terms:

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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases	Neurocognitive Disorders Mental Disorders Insulin Insulin, Globin Zinc Insulin Aspart Hypoglycemic Agents Physiological Effects of Drugs

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