Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could a nasal spray of insulin help Parkinson's symptoms?

NCT ID NCT04251585

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Feb 2020

Finished

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Parkinson disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Insulin Resistance Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota, 55130, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.