Memory and Insulin in Early Alzheimer's Disease

NCT ID: NCT00581867

Last Updated: 2015-07-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-05-31

Brief Summary

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To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.

Detailed Description

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Functional MRI study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early Alzheimer's disease and cognitively normal older adults. The role of the apoE-e4 allele in modulating brain insulin responses is also addressed.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intranasal Insulin Aspart

Participants were administered intranasal insulin aspart (40 IU) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

Group Type EXPERIMENTAL

Insulin Aspart

Intervention Type DRUG

40IU insulin aspart applied intranasally

Intranasal Saline (placebo)

Participants were administered intranasal saline (placebo) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Insulin Aspart

40IU insulin aspart applied intranasally

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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intranasal insulin saline

Eligibility Criteria

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Inclusion Criteria

* Patients with Early Alzheimer's disease

Exclusion Criteria

* Patients with Late Alzheimer's disease
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jeff Burns, MD

OTHER

Sponsor Role lead

Responsible Party

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Jeff Burns, MD

Professor, Associate Director University of Kansas Alzheimer's Disease Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeffrey M Burns, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center, Hoglund Brain Imaging Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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10896

Identifier Type: -

Identifier Source: org_study_id

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