Safety, Tolerability and Effects of Mannitol in Parkinson's Disease (PD-mannitol)

Hadassah Medical Center

Status and phase: Unknown; Phase 2

Conditions: Parkinson Disease

Treatments: Dietary Supplement: Oral D-Mannitol of Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03823638

0346-17-HMO-CTIL

Details and patient eligibility

About

Parkinson's disease is a progressive neurodegenerative disease that causes disabling motor and cognitive impairments. Currently, no disease-modifying therapy exists for this disease. Mannitol, a naturally-occurring substance, which is commonly used as sweetener, was offered as such agent. In this phase II, safety, tolerability-based dose finding, and efficacy study, mannitol or placebo (dextrose) in escalating doses will be given to patients with Parkinson's disease for 36 weeks.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ability to understand and signing of informed consent form.
2. Age 40-75 years at the day of visit 1.
3. Diagnosis of Parkinson's disease that is based on the United Kingdom brain bank criteria diagnosed after the age of 40.
4. Stable regime of anti-parkinsonian medication for at least 4 weeks at the day of visit 1.

Exclusion criteria

1. Patients with motor deficits that require administration of symptomatic therapy more than 4 times per day at the day of visit 1.
2. Patients on advanced therapy for Parkinson's disease (sub-cutaneous apomorphine, deep brain stimulation or intra-jejunal levodopa infusion).
3. Patients with dementia reflected by a Mini-mental state examination (MoCA) ≥ 24.
4. Patient with legal guardian.
5. History of psychosis or use of dopamine receptor blocking agent on the year proceeding at the visit 1. Quetiapine at dose lower or equal 50 mg per day prescribed for indication other than psychosis is allowed.
6. Suspected Parkinsonian syndrome other than Parkinson's disease.
7. Use of medical marihuana on the month proceeding visit 1.
8. Pregnant or lactating women, or fertile woman who does not use contraceptive. Woman of child-bearing potential must have a negative urine Human chorionic gonadotropin (hCG) and will be monitored by repeated urine tests.
9. Patient with significantly impaired renal functions (urea or creatinine values 20% above the upper norm limit).
10. Diabetes mellitus.
11. Clinical evidence for congestive heart failure.
12. Patient with symptomatic orthostatic hypotension.
13. Based on investigator's opinion, any medical condition that may progress due to consumption of oral mannitol or glucose.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

D-Mannitol

Experimental group

Description:

Oral Supplement of the investigated substance: D-Mannitol powder (manufacturer Roquette)

Treatment:

Dietary Supplement: Oral D-Mannitol of Placebo

Placebo

Placebo Comparator group

Description:

Oral Supplement of the placebo: Dextrose monohydrate powder (manufacturer Roquette)

Treatment:

Dietary Supplement: Oral D-Mannitol of Placebo