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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 150mg dosing | Active Comparator | This arm will take 150mg of Nilotinib by mouth daily for the 6 month drug period to establish a safe and efficacious dose. |
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| 300mg dosing | Active Comparator | This arm will take 300mg of Nilotinib by mouth daily for the 6 month drug period to establish a safe and efficacious dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nilotinib | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in α-synuclein and Tau concentrations in the CSF and serum of patients | Working Hypothesis: PD patients have been shown to have elevated levels of α-synuclein in their CSF. Nilotinib has been shown to reduce α-synuclein and Tau in the gastrointestinal tract and central nervous system in animal models, and similarly, we propose will show changes in CSF and serum α-synuclein concentrations in nilotinib treated PD patients. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determine nilotinib's efficacy by improvement in motor and non-motor symptoms | Working Hypothesis: By following strict safety guidelines, monitoring patients through physical examinations, self-examinations, laboratory and neurological examinations, nilotinib will be a safe drug to use in patients with PD and PD related patients. Determine if any clinical benefit is observed in this small, short, limited clinical trial. Working Hypothesis: In cell culture and animal models of PD, dopaminergic neurons have shown increased cell death with accumulating α-synuclein. Therefore, PD patients treated with nilotinib, which lowers α-synuclein and Tau in vivo and in vitro studies, will have improvement or stabilization of their motor UPDRS and cognition. |
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Inclusion Criteria:
1. Patients aged 40 to 90 with Idiopathic Parkinson's Disease (Significant Sinemet response) on a stable medication drug regimen L-dopa and/or Dopamine agonist (at least 1 month before enrollment with no new medication change) and with moderate to severe cognitive impairment (MOCA ≤24).
Inclusions criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40680102 | Derived | Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 20, 2016 | |
| Reset | Nov 9, 2016 | |
| Release | Aug 24, 2018 | |
| Reset | Feb 4, 2019 | |
| Release | Nov 18, 2019 | |
| Reset | Dec 4, 2019 | |
| Release | Mar 24, 2020 | |
| Reset | Apr 6, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2016 | Nov 9, 2016 | |||
| Aug 24, 2018 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020961 | Lewy Body Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C498826 | nilotinib |
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| 6 months |
| Safety and tolerability, as measured by number of Participants with Adverse Events | Working Hypothesis: By following strict safety guidelines, monitoring patients through physical examinations, self-examinations, laboratory and neurological examinations, nilotinib will be a safe drug to use in patients with PD and PD related patients. Determine if any clinical benefit is observed in this small, short, limited clinical trial. Working Hypothesis: In cell culture and animal models of PD, dopaminergic neurons have shown increased cell death with accumulating α-synuclein. Therefore, PD patients treated with nilotinib, which lowers α-synuclein and Tau in vivo and in vitro studies, will have improvement or stabilization of their motor UPDRS and cognition. | 6 months |
| Feb 4, 2019 |
| Nov 18, 2019 | Dec 4, 2019 |
| Mar 24, 2020 | Apr 6, 2020 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |