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Completed

NCT Number: NCT01145482

Mechanisms of Insulin Facilitation of Memory

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.

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Key information

Conditions

Memory Disorders Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of texas at Austin

Austin, Texas, 78712, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Insulin

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

Other names: NovoLog, 20 IU

Saline

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

Other names: Saline, 200 micro liters

Primary outcomes

  1. Cerebral Glutamate Concentration

    Time frame: 15 minutes post insulin or placebo administration

    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 outcomes

  1. Memory

    Time frame: 15 minutes post insulin or placebo administration

    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

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 16, 2010
Registry last updated
Nov 3, 2014

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.

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