Could a nasal spray of insulin help Parkinson's symptoms?
NCT ID NCT04251585
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested whether insulin sprayed into the nose is safe for people with Parkinson's disease. Over 3 weeks, 31 participants received either intranasal insulin or a placebo. Researchers monitored safety events like low blood sugar and weight loss, and also looked at changes in thinking, mood, and movement. The goal was to see if this approach could be a safe way to potentially ease non-motor and motor symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intranasal insulin (Novolin R)
- What this could lead to
- If it works, this could point toward a simple, non-invasive way to ease thinking and movement problems in Parkinson's disease.
- What could go wrong
- This is a small, early safety trial with only 31 people over 3 weeks. It may not show clear benefits, and insulin can cause low blood sugar or weight loss.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
31 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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Aug 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
41 to 89 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to Movement disorder society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a fellowship trained movements disorder specialist * Subject is Hoehn \& Yahr stage less than or equal to 3 * Subject has a MOCA score ≥10. * Subject is \> 40 and \<90 years of age. * Female subjects are post-menopausal or have a negative pregnancy test * The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology. * Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative. * Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and is willing to remain on this dose for the duration of the study. If the subject is on a cholinesterase inhibitor, a stable dose without changes for 1 month is also required. * Subject has undergone a brain CT or MRI prior to the study as part of their previous diagnostic workup for PD to rule out underlying structural lesions, as determined clinically significant by the investigator Exclusion Criteria: * Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia) * Subject has medical history and/or clinically determined disorders: chronic sinusitis, untreated thyroid disease, or significant head trauma. * Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator. * Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies. * Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator. * Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator. * Subject has undergone a recent change (\<1 month) in their anti-parkinsonian medication, cholinesterase inhibitor or anti-depressant medication. * Subject has current or recent drug or alcohol abuse or dependence as defined by Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV TR). * Screening laboratory results that are medically relevant, in which inclusion would pose a safety risk to the subject as determined by investigator. * Subject has participated in a clinical trial investigation within 3 months of this study. * Subject has an insulin allergy. * Subject has Insulin-dependent diabetes
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130, United States
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