Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.

Peter Novak

Status and phase: Completed; Phase 2

Conditions: Multiple System Atrophy; Parkinson Disease

Treatments: Drug: Intranasal Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02064166

PN-1

Details and patient eligibility

About

Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative disorders characterized by abnormal accumulation of α-synuclein. There is no effective treatment that can slow down the disease progression and both disorders are associated with severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and memory in healthy and cognitively impaired non-diabetic adults.

The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322) has shown that a single 40 international units dose of intranasal insulin improves visuospatial memory in diabetes and control subjects.

This proposal includes randomized, double blinded, placebo-controlled trial of intranasal insulin (40 international units daily) in treatment of PD and MSA.

The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of the cognitive scale ratings.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males or females older than 17 years.
2. Clinical diagnosis of Parkinson disease or multiple system atrophy.
3. Provide written informed consent to participate in the study.
4. Understand that they may withdraw their consent at any time.

Exclusion criteria

1. Women who are pregnant or lactating.
2. In the investigator's opinion, have significant systemic, hepatic, cardiovascular, renal or other illness that can interfere based on investigator judgment with the trial.
3. History of dementia.
4. Unable to walk without help for at least 1 minute.
5. History of allergic reaction to insulin.
6. The presence of inflammation of nasal cavity that may prevents absorption of insulin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Insulin

Experimental group

Description:

40 IU of intranasal insulin daily

Treatment:

Drug: Intranasal Insulin

Placebo

Placebo Comparator group

Description:

Placebo arm using intranasal normal saline

Treatment:

Drug: Intranasal Insulin