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

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin aspart
Placebo
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Wake Forest Baptist Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Insulin Aspart

Placebo

Arm Description

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.

Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.

Outcomes

Primary Outcome Measures

Change in cognition
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

Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers
MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions

Full Information

First Posted
June 1, 2015
Last Updated
May 8, 2020
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA), General Electric
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1. Study Identification

Unique Protocol Identification Number
NCT02462161
Brief Title
Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart
Acronym
SNIFF-Quick
Official Title
Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2015 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA), General Electric

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Aspart
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Insulin aspart
Other Intervention Name(s)
NovoLog Fast-Acting Insulin Aspart
Intervention Description
Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Participants will administer placebo two times per day with an intranasal delivery device.
Primary Outcome Measure Information:
Title
Change in cognition
Description
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)
Time Frame
6 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
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
Title
MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions
Time Frame
Baseline and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Craft, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart

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