Phase IIb Study of Intranasal Glutathione in Parkinson's Disease

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Glutathione is an important nutrient for brain function and loss of glutathione has been implicated in Parkinson's disease. Glutathione is an antioxidant made in the body out of three amino acids, the nutrients that make up protein. This study will determine whether administration of either dose of glutathione, as a nasal spray, improves PD symptoms over time in a population of individuals with Parkinson's disease (PD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bastyr University
• Collaborator: Michael J. Fox Foundation for Parkinson's Research

Criteria

Inclusion Criteria:

• Diagnosis of PD made by a clinical neurologist within the previous 10 years

• A modified Hoehn & Yahr Stage <3

• Age >21

• Subjects must be able to attend study visits at baseline, weeks 4, 8, 12, and 16.

• Subjects must be able to demonstrate, or have a caregiver administer, medication.

• Dose and frequency of pharmaceutical medications must be stable for 1 month prior to enrollment.

• Dose and frequency of naturopathic medications must be stable for 1 month prior to enrollment.

• Diet, exercise, and medications must be kept constant throughout participation in the study. (Medication changes considered essential by a participant's physician will be permitted and recorded).

• Ability to read and speak English.

• MRI cohort: Additional inclusion criteria specific to MRI.

Exclusion Criteria:

• Dementia as evidenced by a Montreal Cognitive Assessment score of less than 24.

• Diseases with features common to PD (e.g., essential tremor, multiple system atrophy, progressive supranuclear palsy)

• Epilepsy

• A history of stroke

• The presence of other serious illnesses

• Respiratory disease (e.g. asthma, COPD)

• A history of brain surgery

• A history of structural brain disease

• A history of intranasal telangiectasia

• Supplementation with glutathione, and agents shown to increase glutathione, will not be permitted and their use will necessitate a 90-day washout period; this will be required for all forms of glutathione and the glutathione precursor, N-acetylcysteine.

• Pregnant or at risk of becoming pregnant (i.e., unwilling to use birth control if a sexually active, pre-menopausal female). Urine pregnancy tests will be administered to pre-menopausal women.

• MRI cohort: Additional exclusion criteria specific to MRI.