Nilotinib in Cognitively Impaired Parkinson Disease Patients 001
United States12 participantsStarted 2014-11
Plain-language 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.
Who can participate
Age range40 Years – 90 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Capability and willingness to comply with the study related criteria
✓. Patients between the age of 40-90 y
✓. Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria
✓. Early PD subjects with MMSE between 23-30.
✓. Hoehn and Yahr stage \<2
✓. Stable treatment (\>4 weeks) with MAO-B inhibitor (Selegeline up to 10mg/d or rasagiline up to 1 mg/d) allowable
✓. Patients not needing dopamine agonist or levodopa therapy presently or at least for the next 6 months
Exclusion criteria
✕. Patients with a known genetic form of PD that does not involve alpha-synuclein.
✕. Unwillingness to undergo lumbar punctures
What they're measuring
1
Change in α-synuclein and Tau concentrations in the CSF and serum of patients