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

Part of paid clinical trials in Davie, Florida.

Sponsor
Gateway Institute for Brain Research
Study ID
NCT05266417
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • INS-GSH — DRUG
    Intranasal INS-GSH Twice Daily
  • Matched Placebos — DRUG
    Intranasal Matched Placebos Twice Daily

Study Details

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

Key Dates

Start date
Feb 7, 2022
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Jul 30, 2027

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active
    Insulin (Novolin R) and Glutathione (INS-GSH)
  • Placebo Comparator: Control
    Placebo

Primary Outcome Measure

Verbal Fluency [ Time Frame: 24 Weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Institute for Neuroimmune MedicineDavieFlorida33314
Rafael Iglesias
954-262-2876
Irina Rozenfeld, DPN, APRN (PRINCIPAL_INVESTIGATOR)
Las Mercedes Medical ResearchHialeahFlorida33012
Elivra Grana
786-577-5977
Millie Silberberg
786-577-5977
Frank Alvarez, MD (PRINCIPAL_INVESTIGATOR)
NextGen Research GroupMiamiFlorida33165
Dayana Rojas, PhD, MPH
786-427-9659
Luis Rodriguez
(645) 229-4543

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