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Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart (SNIFF-Quick)

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ClinicalTrials.gov Identifier: NCT02462161
Recruitment Status : Recruiting
First Posted : June 3, 2015
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
National Institute on Aging (NIA)
General Electric
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition, daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid deposition in the brain. Participants will be randomly assigned to receive insulin aspart or placebo during a 12-week treatment period.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Drug: Insulin aspart Drug: Placebo Phase 1

Detailed Description:

A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels.

This trial will consist of a randomized double-blind, placebo-controlled parallel group trial in which 30 participants with AD or mild cognitive impairment (MCI) receive twice daily intranasal administrations of insulin aspart (20 IU) or placebo (saline), two times per day for 12 weeks. All participants will appoint a "support person" to answer a collateral questionnaire and supervise the administration of the study drug. All participants and study partners will undergo the intensive, structured training program in the self-management of intranasal insulin administration. Cognitive testing and blood collection will occur at baseline, after 6 weeks of treatment, and at the end of the 12 week treatment period. Participants will also receive a lumbar puncture to measure AD biomarkers in the subject's cerebral spinal fluid.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart
Study Start Date : May 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Insulin Aspart
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of insulin aspart (20 IU) for 12 weeks.
Drug: Insulin aspart
Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.
Other Name: NovoLog Fast-Acting Insulin Aspart

Placebo Comparator: Placebo
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.
Drug: Placebo
Participants will administer placebo two times per day with an intranasal delivery device.
Other Name: Saline




Primary Outcome Measures :
  1. Change in cognition [ Time Frame: 6 weeks and 12 weeks ]
    Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog)/mild cognitive impairment (MCI) scores and memory composite (summed Z scores from delayed story and list recall)


Secondary Outcome Measures :
  1. Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers [ Time Frame: Blood - every 6 weeks for 12 weeks; cerebral spinal fluid (CSF) - baseline and week 12 ]
  2. MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions [ Time Frame: Baseline and week 12 ]


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Ages Eligible for Study:   50 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous or subsequent diagnosis of Alzheimer's disease or mild cognitive impairment
  • Ability to communicate in English

Exclusion Criteria:

  • Preexisting diabetes
  • Clinically significant elevations in liver function test
  • Clinically significant elevations in lipid profile
  • Prior lumbar lumbar surgeries or other medical conditions that render lumbar punctures unsafe
  • Hemoglobin <8 g/dl
  • Significant neurologic disease that might affect cognition, other than Alzheimer's disease, including stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury (within the last year) with loss of consciousness >30 minutes or with permanent neurologic 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 antipsychotic, anticonvulsant, anxiolytic, anticoagulant or sedative medications
  • Current or previous use of glucose-lowering agents or insulin;
  • Chronic use (≥ 3 times per week) of nasal sprays of any type for any indication
  • Premenopausal status (defined as having had a period within the last year).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462161


Contacts
Contact: Deborah Dahl, RN 336-713-3432 ddahl@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Hospital Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Deborah Dahl    336-713-3432    ddahl@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Aging (NIA)
General Electric
Investigators
Principal Investigator: Suzanne Craft, PhD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02462161     History of Changes
Other Study ID Numbers: IRB00026106
5P50AG005136-30 ( U.S. NIH Grant/Contract )
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs