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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581867
First Posted: December 28, 2007
Last Update Posted: July 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jeff Burns, MD, University of Kansas Medical Center Research Institute
  Purpose
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 Intervention Phase
Alzheimer's Disease Drug: Insulin Aspart Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jeff Burns, MD, University of Kansas Medical Center Research Institute:

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.


Enrollment: 31
Study Start Date: October 2007
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

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

Responsible Party: Jeff Burns, MD, Professor, Associate Director University of Kansas Alzheimer's Disease Center, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00581867     History of Changes
Other Study ID Numbers: 10896
First Submitted: December 19, 2007
First Posted: December 28, 2007
Results First Submitted: January 9, 2014
Results First Posted: July 14, 2015
Last Update Posted: July 14, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs