NCT02462161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

July 28, 2025

Status Verified

August 1, 2019

Enrollment Period

4.1 years

First QC Date

June 1, 2015

Last Update Submit

July 25, 2025

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Outcome Measures

Primary Outcomes (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)

    6 weeks and 12 weeks

Secondary Outcomes (2)

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

    Blood - every 6 weeks for 12 weeks; cerebral spinal fluid (CSF) - baseline and week 12

  • MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions

    Baseline and week 12

Study Arms (2)

Insulin Aspart

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Insulin aspartDRUG

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

Also known as: NovoLog Fast-Acting Insulin Aspart
Insulin Aspart
PlaceboDRUG

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

Also known as: Saline
Placebo

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

Insulin AspartSodium Chloride

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Suzanne Craft, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 3, 2015

Study Start

March 20, 2015

Primary Completion

April 16, 2019

Study Completion

April 16, 2019

Last Updated

July 28, 2025

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)