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CompletedNCT01547169SNIFF-LONG 21Updated Dec 18, 2012

Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days

A Phase 2 interventional study of Placebo Comparator and insulin detemir in Alzheimer's Disease and Mild Cognitive Impairment, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 50 Years to 89 Years. Per ClinicalTrials.gov, last updated 2012-12-18.

Sponsored by University of Washington · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
50 Years to 89 Years
Sex
All
01

Study summary

The study will examine the effects of intranasally administered long-acting insulin detemir on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment (aMCI). The rationale for these studies is derived from growing evidence that insulin contributes to multiple brain functions, and that insulin dysregulation can contribute to AD pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have beneficial effects on brain function. Intranasal administration of insulin increases insulin signaling in brain without raising peripheral levels and causing hypoglycemia. Insulin detemir is an insulin analogue that may have better action in brain than other insulin formulations because of its albumin binding properties. The investigators will test the therapeutic effects of intranasally-administered insulin detemir in a dose-finding study in which participants will receive one of two doses of insulin detemir or placebo for a three week period. The investigators will test the hypothesis that either dose will improve memory and daily functioning in persons with AD/aMCI compared with placebo.

Read the detailed description

It is well-known that insulin, a hormone that is naturally secreted by the pancreas, plays an important physiological role by regulating blood sugar levels in the body. The investigators now know that insulin plays many important roles in the brain as well. Insulin seems to be especially active in the part of the brain that corresponds to learning and memory. Studies have shown that when people have insufficient insulin in the brain (which, for example, is the case with Type-II diabetes), they are increasingly at risk to develop memory problems and Alzheimer's disease. In a past study, the investigators administered intravenous insulin to participants and found that it improves their memory. However, that particular method would not be a practical intervention for people with Alzheimer's disease due to the risk of hypoglycemia or exacerbation of insulin resistance. Instead, the investigators use an "intranasal" method of administration, in which the insulin is inserted into a device, and administered intranasally. In this method, the insulin travels directly to the brain, and bypasses the body. Our past studies have also demonstrated that this can be a reliable way to improve memory, and it does not change the body's blood glucose levels.

In our past studies, the investigators have used regular insulin, which lasts about 3-4 hours and creates a similar "spike" in insulin that one would have after eating a meal. However, in normal physiology, the pancreas also releases small and more constant "pulses" of insulin throughout the day and night, establishing a base level of insulin. Accordingly, several longer-lasting types of insulin are now available that last closer to 10-12 hours, mimicking that base level of insulin. The current study uses a long-lasting type of insulin called "insulin detemir," to determine if learning and memory will benefit from a more constant supplement of insulin. the investigators want to determine whether this treatment can benefit people who already have a memory impairment-either they already have a diagnosis of Alzheimer's disease or are diagnosed with mild cognitive impairment, a condition that precedes Alzheimer's disease, and whether a lower or higher dose of insulin detemir is more effective. The investigators will examine cognition, daily function, and different markers of Alzheimer's disease that are in the blood as outcome measures.

The investigators have these specific aims:

  1. The investigators will test the hypothesis that compared to placebo, three weeks of treatment with intranasal insulin detemir will improve cognition and function in adults with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
  2. The investigators will determine which of two doses of intranasal insulin detemir produces the greatest improvement in cognition and daily function relative to placebo for adults with AD or MCI.

To examine these hypotheses, the investigators are recruiting approximately 60 participants who have been diagnosed with AD or MCI. They will be randomly selected to take a lower dose of insulin detemir, a higher dose of insulin detemir, or saline (which is an inactive substance and will serve as a placebo). Cognition and the level of daily function will be tested before they begin the study drug, and after 3 weeks of the study drug. The investigators will also measure glucose tolerance and take blood samples to measure markers of AD in the blood.

02

Conditions studied

  • Alzheimer's Disease
  • Mild Cognitive Impairment

Keywords

  • memory
  • intranasal insulin
  • Alzheimer's disease
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 50-89
  • Diagnosed with mild cognitive impairment, or mild/moderate AD

Exclusion criteria

Exclusion Criteria:

  • Excessively high or low blood pressure, heart rate
  • BMI greater than 34
  • Pre-existing diabetes not controlled by exercise
  • Previous/current use of insulin
  • Significant elevations in lipids, liver enzymes
  • Menstrual period within the last 12 months
  • Significant neurological or medical disorder (other than AD)
  • Significant use of nasal decongestants
  • Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or sedative medications
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    Saline

    Drug: Placebo Comparator

  • Experimental
    Low Dose Insulin Detemir (10IU bid)

    Drug: insulin detemir

  • Experimental
    High Dose Insulin Detemir (20IU bid)

    Drug: insulin detemir

Interventions

  • DrugPlacebo Comparator

    saline, taken twice per day for a 3 week duration

  • Druginsulin detemir

    10IU of insulin detemir, administered intranasally twice per day for a 3 week duration

    Also known as: Levemir

  • Druginsulin detemir

    20IU insulin detemir, administered intranasally twice per day for a 3 week duration

    Also known as: Levemir

06

What researchers measure

Primary outcomes

  1. Verbal Memory Composite

    The composite will consist of the weighted sum of Immediate + Delayed Story Recall and Immediate +Delayed List Recall

    Time frame: Change from Baseline in Verbal Memory at 3 Weeks

Secondary outcomes

  1. Neuropsychological Test of Executive Function 1

    Computerized Dot Counting Test (test of executive functioning)

    Time frame: Change from Baseline in Executive Functioning at 3 Weeks

  2. Glucose Tolerance

    Subjects will undergo oral glucose tolerance test (OGTT) to assess glucose tolerance

    Time frame: Change from Baseline in Glucose Tolerance at 3 Weeks

  3. Functional Ability

    Subjects will have a collateral informant (i.e., spouse or friend) rate the subjects' ability to carry out activities of daily living on the Dementia Severity Rating Scale.

    Time frame: Change from Baseline in Functional Ability at 3 Weeks

  4. Plasma biomarkers of AD

    Plasma Abeta (ABeta 38, ABeta 40, and Abeta 42) and Tau (total tau and phosphorylated tau) will be measured in each subject.

    Time frame: Change from Baseline in Plasma Biomarkers at 3 Weeks

  5. Neuropsychological Test of Executive Functioning 2

    Computerized Stroop Test

    Time frame: Change from Baseline in Executive Functioning at 3 Weeks

  6. Neuropsychological Tests of Visual Working Memory

    Benton Visual Retention Test Form F\&G (a test of visual working memory)

    Time frame: Change from Baseline in Visual Working Memory at 3 Weeks

07

Study locations

1 site
  • VA Puget Sound Health Care System
    Seattle, Washington 98108, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01547169
Lead sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
Responsible party
Suzanne Craft (Professor, University of Washington) — Principal investigator
First posted
Mar 7, 2012
Start date
Mar 2011
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Dec 18, 2012

Study contacts

Suzanne Craft, PhD
principal investigator · VA Puget Sound Health Care System; University of Washington School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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