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



Status:Completed
Conditions:Other Indications, Parkinsons Disease
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:11/24/2018
Start Date:February 2014
End Date:September 2015

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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.


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.
We found this trial at
1
site
55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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