Mechanisms of Insulin Facilitation of Memory

NCT01145482 | Completed Results DMC

• 1 other identifier: 2010-05-0007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Disorders

Keywords

Memory Disorders; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  15 minutes post insulin or placebo administration

Secondary Outcomes (1)

• Memory

  15 minutes post insulin or placebo administration

Study Arms (2)

insulin

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

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

Also known as: NovoLog, 20 IU

insulin

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

Also known as: Saline, 200 micro liters

Saline

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Memory Disorders; Alzheimer Disease

Interventions

Insulin; Insulin Aspart; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Andreana Haley
• Organization: The University of Texas at Austin

haley@psy.utexas.edu

512-232-0863

Study Officials

• Andreana P Haley, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 16, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 3, 2014
• Results First Posted: November 3, 2014

Record last verified: 2014-10

Locations

US (1)