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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease, Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02462161

Run by

Wake Forest University Health Sciences

People needed

24

Starts

2015-03-20

Expected to finish

2019-04-16

Last updated by the study team

2025-07-28

Who can join

Age: 50 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Wake Forest Baptist Hospital — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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