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CompletedPhase 1

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

Asset

Nilotinib

Listed sites

1

Recruiting sites

-

Enrollment

12

actual

Study population

Lewy body dementia

Key I/E criteria

•MMSE 23-30•MoCA ≤24

Primary endpoint

•Α-synuclein and Tau concentrations in the CSF and serum of patients

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIIT-2014-001
NCT IDNCT02281474

Timeline

Milestones

Study start2014-11 (month precision)
Study first posted2014-11-03estimated
Primary completion2015-05actual (month precision)
Last update posted2015-12-16estimated

Assets

Drug assets

Nilotinib

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age40 Years
Maximum age90 Years
SexAll
Healthy volunteersAccepted

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:

1. Written informed consent

2. Capability and willingness to comply with the study related criteria

3. Patients between the age of 40-90 y

4. Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria

5. Early PD subjects with MMSE between 23-30.

6. Hoehn and Yahr stage <2

7. Stable treatment (>4 weeks) with MAO-B inhibitor (Selegeline up to 10mg/d or rasagiline up to 1 mg/d) allowable

8. Patients not needing dopamine agonist or levodopa therapy presently or at least for the next 6 months

9. Idiopathic PD with NO genetic mutations (autosomal recessive or dominant)

10. Detectable levels of CSF for blood and CSF Alpha-Synuclein

Exclusion criteria

1. Patients with a known genetic form of PD that does not involve alpha-synuclein.

2. Unwillingness to undergo lumbar punctures

3. Immeasurable CSF α-synuclein.

4. Presence of dementia or severe cognitive impairment that would not permit the patient to give adequate feedback for potential side effects.

5. Unwilling to be in an off state for UPDRS assessment.

6. Pre-menopausal women

7. Patients with autosomal recessive (PARKIN, PINK1 or DJ1) or dominant mutations (LRRK2)

8. Patients with hypokalemia, hypomagnesaemia, or long QT syndrome.

9. Concomitant drugs known to prolong the QT interval

10. Strong CYP3A4 inhibitors

11. Any drugs or foods that may interact with Nilotinib as stated in the Package Insert (PI).

12. Medical history of liver and pancreatic diseases.

13. Clinical signs indicating syndromes other than idiopathic PD, including supranucelar gaze palsy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar sings, early severe autonomic involvement, Babinski's signs.

14. History of any cardiovascular disease, including hypertension, myocardial infraction or cardiac failure, angina, arrhythmia.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
2
Fluid / digital biomarkers
1

Fluid / digital biomarkers

1 endpoint
Primary/protocol endpoint

Change in α-synuclein and Tau concentrations in the CSF and serum of patients

Time frame:6 months

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Determine nilotinib's efficacy by improvement in motor and non-motor symptoms

Time frame:6 months

change from baseline, event

Secondary/protocol endpoint

Safety and tolerability, as measured by number of Participants with Adverse Events

Time frame:6 months

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.