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Alzheimer's DiseasePhase 1SNIFF-QuickNCT02462161

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

A Phase 1 study testing Insulin aspart in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 89 years
What is being tested?
Insulin aspart
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
20 Mar 2015to 16 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wake Forest Baptist Hospital

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Read the 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.

Being tested
Insulin aspart, Placebo
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin aspartDrug

    Also called NovoLog Fast-Acting Insulin Aspart

    Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.

  • PlaceboDrug

    Also called Saline

    Participants will administer placebo two times per day with an intranasal delivery device.

Study groups in NCT02462161
Study groupRoleWhat they receive
Insulin AspartExperimentalFifteen 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.
Receives: Drug: Insulin aspart
PlaceboPlacebo comparatorFifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 weeks and 12 weeks

Secondary outcomes (2)

  1. Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers

    Measured: 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

    Measured: Baseline and week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2015 (estimated)
  2. Study start20 Mar 2015
  3. Primary completion16 Apr 2019
  4. Study completion16 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02462161
Sponsor's protocol ID
IRB00026106
Other IDs
5P50AG005136-30
Acronym
SNIFF-Quick
Status last verified
Aug 2019
First submitted
1 Jun 2015
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Insulin aspart in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognition (time frame: 6 weeks and 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02462161.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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