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Mechanisms of Insulin Facilitation of Memory

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreana P. Haley, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01145482
First received: June 15, 2010
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Memory Disorders
Drug: Insulin
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Mechanisms of Insulin Facilitation of Memory

Resource links provided by NLM:


Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Cerebral Glutamate Concentration [ Time Frame: 15 minutes post insulin or placebo administration ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15 minutes post insulin or placebo administration ] [ Designated as safety issue: No ]
    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


Enrollment: 12
Study Start Date: July 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: 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
Other Name: NovoLog, 20 IU
Placebo Comparator: 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
Other: 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
Other Name: Saline, 200 micro liters

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145482

Locations
United States, Texas
University of texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
Principal Investigator: Andreana P Haley, PhD University of Texas at Austin
  More Information

No publications provided

Responsible Party: Andreana P. Haley, Assistant Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01145482     History of Changes
Other Study ID Numbers: 2010-05-0007
Study First Received: June 15, 2010
Results First Received: April 10, 2014
Last Updated: October 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
Memory Disorders
Alzheimer's Disease

Additional relevant MeSH terms:
Memory Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014