Mechanisms of Insulin Facilitation of Memory

NCT ID: NCT01145482

Last Updated: 2014-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-04-30

Brief Summary

The study described in the present application will test the hypothesis that insulin mediated facilitation of memory in Alzheimer's disease (AD) is achieved through enhanced glutamatergic neurotransmission due to improvements in cerebral glucose metabolism. The effect of a single dose of intranasal insulin on memory and cerebral glutamate concentrations in adults with mild AD or amnestic mild cognitive impairment (aMCI), the presumed prodromal phase of AD will be studied. Successful completion of this study may set the stage for a larger-scale treatment trial of intranasal insulin for adults with memory disorders. However, the use of insulin in this manner at this point in time is purely experimental.

Detailed Description

The specific aims of this project will be accomplished through a cross sectional repeated measures design in which 15 participants with mild AD or amnestic MCI will undergo assessments of brain structure and function 15 minutes after a single dose of insulin (20 IU) or placebo. Insulin and placebo conditions will be counterbalanced across participants.

Intranasal insulin or placebo administration: Saline and insulin (NovoLog) will be ordered though the UT Student Health Services Pharmacy (Sharon Roberson, Chief Pharmacist) and stored at 4°C, according to standard pharmacy protocols. Three ml doses of saline or insulin will be packaged in nasal spray bottles (e.g., Spectrum Pharmacy Products bottles 969-17404P and actuators 551-24362P) designed to deliver 100μL dose with each spray. A total volume of 200μL will be delivered during each administration (one 100μL dose in each nostril).

Conditions

Memory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

insulin

20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle

Saline

200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle

Interventions

Insulin

20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle

Intervention Type: DRUG

Saline

200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle

Intervention Type: OTHER

Other Intervention Names

NovoLog, 20 IU; Saline, 200 micro liters

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of probable AD
• Age over 21
• Clinical Dementia Rating of 0.5 or 1.0
• Mini Mental State Exam Score>15

Exclusion Criteria

• preexisting diabetes
• significant neurological disease that might affect cognition, other than AD, including stroke, Parkinson's disease, multiple sclerosis
• severe head injury with loss of consciousness > 30 minutes or with permanent neurological sequelae
• significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
• current use of anti-psychotic or anti-convulsant medications
• current or previous use of hypoglycemic agents or insulin
• MRI contraindications
• claustrophobia
• pregnancy

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Andreana P. Haley

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreana P Haley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

University of texas at Austin

Austin, Texas, United States

Countries

United States

Other Identifiers

2010-05-0007

Identifier Type: -

Identifier Source: org_study_id