Parkinson DiseasePhase 2NOSE-PDNCT05266417
Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease
A Phase 2 study testing INS-GSH in people with Parkinson Disease, run by Gateway Institute for Brain Research at 4 sites in United States.
Trial summary
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- INS-GSH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Feb 2022to 30 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented clinical diagnosis of idiopathic PD
- Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug
- Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted
- If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted.
- If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at least 90 days prior to Screening. Essential changes will be permitted.
Who cannot join
- Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Glycated hemoglobin (HbA1c) level ≥ 6.5%
- History of symptomatic hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with symptoms of hypoglycemia.
- Mini-Mental State Exam (MMSE) score of ≤ 24 at Screening
- Positive COVID-19 test at Screening and/or within 30 days of Screening
- Change in or escalation of dose of a chronic therapeutic agent that has the potential to impair cognitive functioning per investigator within the last 8 weeks of Screening or during the study conduct.
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- Chronic inflammation of nasal cavity, history of recurrent epistaxis, and/or clinically significant medical history of uncontrolled allergic rhinitis, rhino-conjunctivitis, or house dust mite allergy at Screening that may prevent absorption of study treatments.
- Insufficiently controlled respiratory disease (i.e., asthma, COPD).
- History of any significant neurologic or psychiatric disease other than PD
- Current diagnosis of epilepsy and had a history of seizures as an adult within 1 year of Screening, or unexplained recent loss of consciousness, or history of significant head trauma with loss of consciousness
- History of non-lacunar ischemic and/or hemorrhagic stroke with residual neurologic deficits.
- Unstable or uncontrolled cardiac disease that could expose the subject to additional safety risks
- Use of the following medications: Insulin or any other anti-hyperglycemic agent(s) except if used during isolated gestational diabetes, Supplementation with GSH or any medication shown to increase glutathione
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Institute for Neuroimmune Medicine
Davie, Florida, 33314
Rafael Iglesias, 954-262-2876, ri73@nova.edu
Irina Rozenfeld, DPN, APRN
- Recruiting
Las Mercedes Medical Research
Hialeah, Florida, 33012
Elivra Grana, 786-577-5977 ext. 5005, elvira.grana@lmmresearch.com
Millie Silberberg, 786-577-5977, millie.munoz@lmmresearch.com
- Recruiting
NextGen Research Group
Miami, Florida, 33165
Dayana Rojas, PhD, MPH, 786-427-9659, dayana.rojas@nextgenresearchgroup.com
Luis Rodriguez, (645) 229-4543, luis.rodriguez@nextgenresearchgroup.com
- Recruiting
Charter Research
The Villages, Florida, 32162
Alessandra Cuevas, 352-441-2000, Alessandra.Cuevas@charterresearch.com
Jeffrey Norton, MD
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
- Conditions
- Parkinson Disease
- Being tested
- INS-GSH, Matched Placebos
- Keywords
- Insulin, Glutathione, Intranasal
- Medical subject headings
- Parkinson Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS-GSHDrug
Intranasal INS-GSH Twice Daily
Matched PlacebosDrug
Also called Insulin Matched Placebo and Glutathione Matched Placebo
Intranasal Matched Placebos Twice Daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Insulin (Novolin R) and Glutathione (INS-GSH) Receives: Drug: INS-GSH |
| Control | Placebo comparator | Placebo Receives: Drug: Matched Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Fluency
F, A and S (FAS) words test
Measured: 24 Weeks
Secondary outcomes (10)
Verbal Fluency
Change in verbal fluency as assessed by the FAS test
Measured: 28 Weeks
Motor Function
Change in Timed Up and Go (TUG) test
Measured: 24 Weeks
Motor Function
Change in the updated Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score
Measured: 24 Weeks
Motor Function
Change in the updated MDS-UPDRS total score
Measured: 24 Weeks
Motor Function
Change in the Clinical Global Impression (CGI) score
Measured: Week 24
Motor Function
Change in Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD)
Measured: Week 24
Cognitive Function
Change in each of the individual twelve (12) task standardized scores assessed using the Cambridge Brain Sciences (CBS) computerized neuropsychological battery
Measured: Week 24
Non-Motor Function
Change in Hamilton Rating Scale for Depression total score
Measured: Week 24
Patient Reported Outcome
Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) assessment
Measured: Week 24
Patient Reported Outcome
Change in the Patient Global Impression (PGI) score
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start7 Feb 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gateway Institute for Brain Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266417
- Sponsor's protocol ID
- 20-GTY-008-01
- Acronym
- NOSE-PD
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Insulin and Glutathione as an Add-On Therapy in Subjects With Parkinson's Disease (NOSE-PD)
- ClinicalTrials.gov ID
- NCT05266417
- Acronym / sponsor ID
- NOSE-PD / 20-GTY-008-01
- Conditions
- Parkinson Disease
- Keywords
- Insulin, Glutathione, Intranasal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Gateway Institute for Brain ResearchIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: INS-GSHInsulin (Novolin R) and Glutathione (INS-GSH) |
| Control | Placebo comparator | Drug: Matched PlacebosPlacebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented clinical diagnosis of idiopathic PD
- Able to administer study drug or have a caregiver throughout the duration of the study to help administer drug
- Willing to continue diet, exercise and medications reported at baseline consistently throughout participation in the trial. Essential changes are permitted
- If taking PD medications or any nutraceuticals, must be on a stable dose for at least 30 days prior to Screening Visit. Essential changes will be permitted.
- If subject is taking chronic antidepressant or an anxiolytic, must be on a stable dose for at least 90 days prior to Screening. Essential changes will be permitted.
Key exclusion criteria (13 listed)
- Clinical diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Glycated hemoglobin (HbA1c) level ≥ 6.5%
- History of symptomatic hypoglycemia and/or documented plasma glucose levels of ≤ 50 mg/dL with symptoms of hypoglycemia.
- Mini-Mental State Exam (MMSE) score of ≤ 24 at Screening
- Positive COVID-19 test at Screening and/or within 30 days of Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INS-GSHIntranasal INS-GSH Twice Daily | Drug | Active |
| Matched PlacebosAlso: Insulin Matched Placebo and Glutathione Matched PlaceboIntranasal Matched Placebos Twice Daily | Drug | Control |
Primary outcome
Verbal Fluency
Time frame: 24 Weeks
F, A and S (FAS) words test
10 secondary outcomes
Verbal Fluency
Time frame: 28 Weeks
Motor Function
Time frame: 24 Weeks
Motor Function
Time frame: 24 Weeks
Motor Function
Time frame: 24 Weeks
Motor Function
Time frame: Week 24
Motor Function
Time frame: Week 24
Cognitive Function
Time frame: Week 24
Non-Motor Function
Time frame: Week 24
Patient Reported Outcome
Time frame: Week 24
Patient Reported Outcome
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INS-GSH in people with Parkinson Disease, run by Gateway Institute for Brain Research at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana Restrepo, PhD (786-216-5334, srestrepo@gifbr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Fluency (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.