Skip to main content
OpenTrials
Completed

NCT Number: NCT00581867

Memory and Insulin in Early Alzheimer's Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Kansas Medical Center, Hoglund Brain Imaging Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Early Alzheimer's disease

Exclusion criteria

  • Patients with Late Alzheimer's disease

Treatment and study plan

insulin aspart

Drug

40IU insulin aspart applied intranasally

Other names: intranasal insulin

Placebo

Drug

Placebo

Other names: saline

Primary outcomes

  1. fMRI Measure of Hippocampal Activation

    Time frame: 30 minutes After Intervention Administration

    Percentage active voxels of total hippocampal volume of interest

Secondary outcomes

  1. Global Cognition

    Time frame: 90 mins

    Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.

Sponsors and collaborators

Lead sponsor

Jeff Burns, MD

Other

Registry information

Official study title

Intranasal Insulin and Memory in Early Alzheimer's Disease

Acronym: MAIN

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 28, 2007
Registry last updated
Jul 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.