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

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

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

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

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

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

Study placed in the following topic categories:

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:

Hypoglycemic Agents

Physiological Effects of Drugs

Nervous System Diseases

Tauopathies

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

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