NCT02281474

Nilotinib in Cognitively Impaired Parkinson Disease Patients 001

Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood α-Synuclein

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This pilot study will test Nilotinib's ability to alter the abnormal protein build up in Parkinson disease and Diffuse Lewey Body Disease patients . Patients will receive Nilotinib at different doses for 6 months. Patients will then be tested to see if there is change in three areas: 1) has the disease symptoms changed. 2) has levels of a specific misfolded protein changed in the fluid around their brain and spine. 3) Have inflammatory markers changed in the patient's blood and fluid around their brain and spine. If successful, this drug could be used to slow down or stop the progression of disorders that involve abnormal collection of misfolded proteins. However, the main purpose of this pilot study is to check for the safety of using this medication at this level.

Conditions

• Parkinson's Disease
• Parkinson's Disease Dementia
• Diffuse Lewy Body Disease

Interventions

Type	Name	Description
DRUG	Nilotinib

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-05-01
• First posted: 2014-11-03
• Last updated: 2015-12-16

Locations

1 site across 1 country: United States