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

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

This study is currently recruiting participants.

Verified by University of Kansas, November 2008

First Received: December 19, 2007 Last Updated: November 5, 2008 History of Changes

Sponsored by:	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:	Diagnostic, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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 Memory

Drug Information available for: Insulin 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 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Insulin Aspart 40IU insulin aspart applied intranasally
2: Placebo Comparator	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

Contacts

Contact: Pat Laubinger, MPA, BSN

(913) 588-0555

plaubinger@kumc.edu

Locations

United States, Kansas
University of Kansas Medical Center, Hoglund Brain Imaging Center	Recruiting
Kansas City, Kansas, United States, 66160
Contact: Pat Laubinger, MPA, BSN 913-588-0555 plaubinger@kumc.edu
Principal Investigator: Jeffrey M Burns, MD

Sponsors and Collaborators

University of Kansas

Investigators

Principal Investigator:

Jeffrey M Burns, MD

University of Kansas

More Information

No publications provided

Responsible Party:	University of Kansas Medical Center ( Jeffrey M. Burns, MD )
Study ID Numbers:	10896
Study First Received:	December 19, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00581867 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypoglycemic Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Insulin, Asp(B28)-
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Insulin
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Alzheimer Disease
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions

Insulin
Delirium, Dementia, Amnestic, Cognitive Disorders
Hypoglycemic Agents
Mental Disorders
Insulin, Asp(B28)-
Dementia
Tauopathies

ClinicalTrials.gov processed this record on July 02, 2009