Overview

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

Status:
Completed
Trial end date:
2019-04-16
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wake Forest University Health Sciences
Collaborators:
General Electric
National Institute on Aging (NIA)
Treatments:
Insulin
Insulin Aspart
Insulin degludec, insulin aspart drug combination
Insulin, Globin Zinc
Insulin, Long-Acting
Insulin, Short-Acting
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).