Parkinson Disease Clinical Trial
Official title:
A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy
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.
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