Trial · NCT04251585

Intranasal Insulin in Parkinson's Disease

NCT04251585, Phase 2, Completed, HealthPartners Institute; results first posted 2026-02-11

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Intranasal Insulin in Parkinson's Disease. Trials, record NCT04251585. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04251585

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intranasal Insulin in Parkinson's Disease
NCT number: NCT04251585
Status: Completed
Phases: Phase 2
Enrollment: 31 participants, actual
Lead sponsor: HealthPartners Institute
Conditions: Parkinson Disease
Interventions: Regular Novolin R, Placebo
First posted: 2020-02-05
Last updated: 2026-02-11
Results first posted: 2026-02-11

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Safety Measured by Count of Safety Events	3 weeks	Composite safety event - this is a count of either a reduction of fasting glucose to \<70 mg/dL or an unintended reduction of weight \>5%. A larger composite event count indicates a less safe treatment.
Primary	Safety Measured by Fasting Glucose	baseline and 3 weeks	Pre-post change in fasting glucose (mg/dL). A larger decrease in fasting glucose indicates a less safe treatment.
Primary	Safety Measured by Body Weight	baseline and 3 weeks	Pre-post change in body weight (lbs). An unintended decrease in body weight indicates a less safe treatment.
Primary	Safety Measured by the Number of Serious Adverse Events (SAE) and Adverse Events (AE)	3 weeks	Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.
Secondary	Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)	5 weeks	Pre-post difference. Total sum of scores. Range: 0-30. Higher score indicates less memory loss
Secondary	Cognitive Function Measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span	3 weeks	Pre-post difference. Scaled score. Range: 1-19. Forward and backward. Lower score indicates more impairment.
Secondary	Cognitive Function Measured by the Trailmaking Test Part A Time	baseline and 3 weeks	Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Secondary	Cognitive Function Measured by the Trailmaking Test Part B Time	baseline and 3 weeks	Pre-post difference. T-score. Mean: 50, Standard deviation: 10. A higher T-score indicates a better outcome/performance. Clinically, 1-1.5 standard deviations would be significant, 2 standard deviations would be considered abnormal/impaired.
Secondary	Cognitive Function Measured by the Trailmaking Test Parts A & B Errors	3 weeks	Pre-post difference. Total number of errors. No range. More errors indicate more impairment.
Secondary	Cognitive Function Measured by the Judgement of Line Orientation	baseline and 3 weeks	Judgement of Line Orientation is an assessment of visuospatial ability. A Z-score of 0 represents the population mean. Pre-post difference. A positive difference indicates an improvement.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Safety Measured by Count of Safety Events	3 weeks	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Safety Measured by Fasting Glucose	baseline and 3 weeks	mg/dL	MEAN
PRIMARY	Safety Measured by Body Weight	baseline and 3 weeks	pounds	MEAN
PRIMARY	Safety Measured by the Number of Serious Adverse Events (SAE) and Adverse Events (AE)	3 weeks	number of events	MEAN
SECONDARY	Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)	5 weeks	score on a scale	MEAN
SECONDARY	Cognitive Function Measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span	3 weeks	score on a scale	MEAN
SECONDARY	Cognitive Function Measured by the Trailmaking Test Part A Time	baseline and 3 weeks	T-score	MEAN
SECONDARY	Cognitive Function Measured by the Trailmaking Test Part B Time	baseline and 3 weeks	T-score	MEAN
SECONDARY	Cognitive Function Measured by the Trailmaking Test Parts A & B Errors	3 weeks	number of errors	MEAN
SECONDARY	Cognitive Function Measured by the Judgement of Line Orientation	baseline and 3 weeks	Z-score	MEAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group124

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Safety Measured by Count of Safety Events	Low Insulin	0		Participants
Safety Measured by Count of Safety Events	Medium Insulin	0		Participants
Safety Measured by Count of Safety Events	High Insulin	0		Participants
Safety Measured by Count of Safety Events	Placebo	0		Participants
Safety Measured by Fasting Glucose	Low Insulin	-3.8	95% Confidence Interval -6.9 to -1.0	mg/dL
Safety Measured by Fasting Glucose	Medium Insulin	-1.3	95% Confidence Interval -6.8 to 4.2	mg/dL
Safety Measured by Fasting Glucose	High Insulin	-5.9	95% Confidence Interval -10 to -1.8	mg/dL
Safety Measured by Fasting Glucose	Placebo	-3.8	95% Confidence Interval -9.8 to 2.1	mg/dL
Safety Measured by Body Weight	Low Insulin	-0.63	95% Confidence Interval -1.8 to 0.50	pounds
Safety Measured by Body Weight	Medium Insulin	0.34	95% Confidence Interval -1.6 to 2.3	pounds

1 to 10 of 124Source ClinicalTrials.gov

See all 124 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Insulin	6
Overall Study	STARTED	Medium Insulin	7
Overall Study	STARTED	High Insulin	10
Overall Study	STARTED	Placebo	6
Overall Study	COMPLETED	Low Insulin	6
Overall Study	COMPLETED	Medium Insulin	7
Overall Study	COMPLETED	High Insulin	9
Overall Study	COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Low Insulin	0
Overall Study	NOT COMPLETED	Medium Insulin	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nasal irritation	Skin and subcutaneous tissue disorders	Low Insulin	4	6	4
other	Nasal irritation	Skin and subcutaneous tissue disorders	Medium Insulin	6	7	11
other	Nasal irritation	Skin and subcutaneous tissue disorders	High Insulin	6	9	8
other	Nasal irritation	Skin and subcutaneous tissue disorders	Placebo	3	6	3
other	Muscle aches, pains, and sprains	Musculoskeletal and connective tissue disorders	Low Insulin	1	6	1
other	Muscle aches, pains, and sprains	Musculoskeletal and connective tissue disorders	Medium Insulin	1	7	1
other	Muscle aches, pains, and sprains	Musculoskeletal and connective tissue disorders	High Insulin	0	9	0
other	Muscle aches, pains, and sprains	Musculoskeletal and connective tissue disorders	Placebo	1	6	1
other	Respiratory/sinus symptoms	Respiratory, thoracic and mediastinal disorders	Low Insulin	2	6	3
other	Respiratory/sinus symptoms	Respiratory, thoracic and mediastinal disorders	Medium Insulin	0	7	0

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low Insulin	0	6
Total, all-cause mortality	Medium Insulin	0	7
Total, all-cause mortality	High Insulin	0	9
Total, all-cause mortality	Placebo	0	6
Total, other adverse events	Low Insulin	6	6
Total, other adverse events	Medium Insulin	7	7
Total, other adverse events	High Insulin	9	9
Total, other adverse events	Placebo	6	6
Total, serious adverse events	Low Insulin	0	6
Total, serious adverse events	Medium Insulin	0	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42780868	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests6

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Digit Span Test	Secondary outcome	ConductCognition
Short Story Recall	Secondary outcome	ConductCognition
Stroop Color-Word Test	Secondary outcome	ConductCognition
Trail Making Test A	Secondary outcome	ConductCognition
Trail Making Test B	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04251585

GET https://conductscience.org/api/trials/v1/NCT04251585/registered?page=2

API reference For AI assistants