Memory and Insulin in Early Alzheimer's Disease - Full Text View

Sponsor:	University of Kansas
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00581867

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 II

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Diabetes Medicines Memory

Drug Information available for: Insulin Insulin beef Insulin aspart

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 ]

Estimated Enrollment:	36
Study Start Date:	October 2007
Estimated Study Completion Date:	May 2012
Estimated 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

University of Kansas

Investigators

Principal Investigator:

Jeffrey M Burns, MD

University of Kansas

More Information

No publications provided

Responsible Party:	Jeffrey M. Burns, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT00581867 History of Changes
Other Study ID Numbers:	10896
Study First Received:	December 19, 2007
Last Updated:	February 16, 2011
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 February 12, 2012