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Testing add-on treatments given through the nose

Researchers compare insulin and glutathione given through the nose with an inactive treatment, checking safety and effects in Parkinson’s.

Testing a treatment or activity · Study reference: NCT05266417

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

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Looking for volunteers

Start (reported actual date)
2022-02-07
Main measurements finished (planned)
2027-09-01
Study finished (planned)
2027-11-30

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 30 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Key Inclusion Criteria: * 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: * 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. * 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
Full study name & original research details

Official study 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)

Short title used by the registry

Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

Original description

This study will be evaluating the safety and efficacy of insulin and glutathione in subjects with Parkinson's Disease compared to placebo.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
INS-GSH; Matched Placebos
Phases
PHASE2
Sponsor
Gateway Institute for Brain Research
Start date reported by registry
2022-02-07 (actual)

Registry updated: 2026-07-22 · Status last verified by the registry submitter: 2026-07

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Susana Restrepo, PhD · 786-216-5334 · srestrepo@gifbr.com

Vanesa Javier · 954-636-2166 · vaday@gifbr.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Institute for Neuroimmune Medicine

Davie, Florida, United States

Recruiting

Rafael Iglesias · 954-262-2876 · ri73@nova.edu

Irina Rozenfeld, DPN, APRN

Las Mercedes Medical Research

Hialeah, Florida, United States

Recruiting

Elivra Grana · 786-577-5977 · elvira.grana@lmmresearch.com

Millie Silberberg · 786-577-5977 · millie.munoz@lmmresearch.com

Frank Alvarez, MD

NextGen Research Group

Miami, Florida, United States

Recruiting

Dayana Rojas, PhD, MPH · 786-427-9659 · dayana.rojas@nextgenresearchgroup.com

Luis Rodriguez · (645) 229-4543 · luis.rodriguez@nextgenresearchgroup.com

Charter Research

The Villages, Florida, United States

Recruiting

Alessandra Cuevas · 352-441-2000 · Alessandra.Cuevas@charterresearch.com

Jeffrey Norton, MD

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.