Memory and Insulin in Early Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— MAIN  

Official title:

Intranasal Insulin and Memory in Early Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581867
• Other study ID #: 10896
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 19, 2007
• Last updated: July 10, 2015
• Start date: October 2007
• Est. completion date: May 2012

Study information

• Verified date: July 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients with Early Alzheimer's disease

Exclusion Criteria:

• Patients with Late Alzheimer's disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Insulin Aspart
40IU insulin aspart applied intranasally
• Placebo
Placebo

Locations

Country	Name	City	State
United States	University of Kansas Medical Center, Hoglund Brain Imaging Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Jeff Burns, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI Measure of Hippocampal Activation	Percentage active voxels of total hippocampal volume of interest	30 minutes After Intervention Administration	No
Secondary	Global Cognition	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.	90 mins	No