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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeff Burns, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00581867
First received: December 19, 2007
Last updated: July 10, 2015
Last verified: July 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 University of Kansas:

Primary Outcome Measures:
  • fMRI Measure of Hippocampal Activation [ Time Frame: 30 minutes After Intervention Administration ] [ Designated as safety issue: No ]
    Percentage active voxels of total hippocampal volume of interest


Secondary Outcome Measures:
  • Global Cognition [ Time Frame: 90 mins ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 19, 2007
Results First Received: January 9, 2014
Last Updated: July 10, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Insulin
Insulin Aspart
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 02, 2015