Memory and Insulin in Early Alzheimer's Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

December 19, 2007

Last Updated Date

September 18, 2009

Start Date ^ICMJE

October 2007

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

fMRI activation [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00581867 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cognitive testing [ Time Frame: 2 Hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Memory and Insulin in Early Alzheimer's Disease

Official Title ^ICMJE

Intranasal Insulin and Memory in Early Alzheimer's Disease

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: Insulin Aspart
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients with Early Alzheimer's disease

Exclusion Criteria:

Patients with Late Alzheimer's disease

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00581867

Responsible Party

Jeffrey M. Burns, MD, University of Kansas Medical Center

Study ID Numbers ^ICMJE

10896

Study Sponsor ^ICMJE

University of Kansas

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jeffrey M Burns, MD

University of Kansas

Information Provided By

University of Kansas

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP