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Mechanisms of Insulin Facilitation of Memory

Primary Purpose

Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Insulin
Saline
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Memory Disorders focused on measuring Memory Disorders, Alzheimer's Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

insulin

Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cerebral Glutamate Concentration
Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.

Secondary Outcome Measures

Memory
Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance

Full Information

First Posted
June 15, 2010
Last Updated
October 30, 2014
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT01145482
Brief Title
Mechanisms of Insulin Facilitation of Memory
Official Title
Mechanisms of Insulin Facilitation of Memory
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders
Keywords
Memory Disorders, Alzheimer's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin
Arm Type
Experimental
Arm Description
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
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
NovoLog, 20 IU
Intervention Description
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
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
Saline, 200 micro liters
Intervention Description
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
Primary Outcome Measure Information:
Title
Cerebral Glutamate Concentration
Description
Glutamate concentration was expressed as the ratio of glutamate to creatine. This was determined using magnetic resonance spectroscopy (MRS), a magnetic resonance technique that uses the same equipment as magnetic resonance imaging (MRI), but allows researchers to extract information about the concentrations of various neurochemicals of neurobiological significance.
Time Frame
15 minutes post insulin or placebo administration
Secondary Outcome Measure Information:
Title
Memory
Description
Memory performance was assessed using delayed recall (number of units recalled) on the Wechsler Memory Scale (WMS-IV) logical memory (story recall) test. Scores represent a sum of recalled units of two different stories after a 30 minute delay. Total scores range from 0 to 50 (0-25 for each story) with higher scores reflecting better memory performance
Time Frame
15 minutes post insulin or placebo administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreana P Haley, PhD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States

12. IPD Sharing Statement

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Mechanisms of Insulin Facilitation of Memory

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