Trial record 9 of 268 for:    Open Studies | memory

Mechanisms of Insulin Facilitation of Memory

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Texas at Austin
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: January 15, 2013
Last verified: January 2013
  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
Insulin
Drug: NovoLog Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group 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 will be measured non-invasively using 1H MRS


Secondary Outcome Measures:
  • cognitive performance [ Time Frame: 15 minutes post insulin or placebo administration ] [ Designated as safety issue: No ]
    memory, executive function, mental status


Estimated Enrollment: 25
Study Start Date: July 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin
within subjects placebo controlled design - everyone will receive intervention (insulin) and placebo (saline) during separate visits
Drug: NovoLog Insulin
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).
Other Name: NovoLog

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

Contacts
Contact: Katayoon Karimi Goudarzi, MD, MA +1 (512) 471-7926 neurolab.ut@gmail.com
Contact: Andreana P Haley, PhD +1 (512) 232-0863 haley@mail.psy.utexas.edu

Locations
United States, Texas
University of texas at Austin Recruiting
Austin, Texas, United States, 78712
Contact: Katayoon K Goudarzi, MD,MA    512-471-7926    neurolab.ut@gmail.com   
Principal Investigator: Andreana P Haley, PhD         
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
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
Memory
Insulin
Alzheimer disease

Additional relevant MeSH terms:
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014