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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: June 22, 2012
Last verified: June 2012
History of Changes
  Purpose

To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease


Condition Intervention Phase
Alzheimer's Disease
 Drug: Insulin Aspart
Drug: Placebo
 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: Diagnostic
Official Title: Intranasal Insulin and Memory in Early Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • fMRI activation [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive testing [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]

Enrollment: 30
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: 1 Drug: Insulin Aspart
40IU insulin aspart applied intranasally
Placebo Comparator: 2 Drug: Placebo
Placebo

Detailed Description:

Functional MRI study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early Alzheimer's disease. 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
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, Assistant Professor, Director of the Alzheimer & Memory Center & AD Clinical Research Program, 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
Last Updated: June 22, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013