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CompletedNCT03888222Updated Jul 10, 2026Results posted

Impact of Bosutinib on Safety, Tolerability, Biomarkers and Clinical Outcomes in Dementia With Lewy Bodies

A Phase 2 interventional study of Placebo Oral Tablet and Bosutinib Oral Tablet in Dementia With Lewy Bodies, sponsored by Georgetown University. Completed at 1 site in United States. Open to participants aged 25 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Georgetown University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
25 Years to 90 Years
Sex
All
01

Study summary

This study evaluates the effect of Bosutinib (Bosulif,Pfizer®) in the treatment of patients with Dementia with Lewy Bodies. Half participants will receive 100 mg of Bosutinib , while the other half will receive placebo.

Read the detailed description

This proposal will evaluate the effects of Bosutinib (Bosulif, Pfizer®) treatment - an FDA-approved tyrosine kinase inhibitor that targets c-Abelson (Abl) and Src tyrosine kinases- in patients with DLB. Investigators have demonstrated safety and efficacy of this compound in pre-clinical animal models and others have shown similar benefits of Bosutinib on inflammation and neurotoxic protein clearance in neurodegeneration. Investigators have demonstrated that Bosutinib enters the brain (5% CSF:plasma ratio) and inhibits Abl at lower doses (5mg/kg) than the cancer dose (80mg/kg) in animals. Bosutinib also reduces the levels of neurotoxic proteins including alpha-synuclein, tau and beta-amyloid and improves motor and cognitive behavior in models of neurodegeneration. The use of Bosutinib is a novel strategy that promotes autophagy to clear neurotoxic protein aggregates in neurons. Bosutinib is FDA-approved for the treatment of chronic myelogenous leukemia (CML) at an oral dose of 400-600 mg daily. Based on our preclinical evidence, investigators used allometric conversion to extrapolate animal to human dose and estimated a human equivalent dose daily dose of 100mg Bosutinib in this clinical study to determine the safety and tolerability, pharmacokinetics and pharmacodynamics in patients with mild to moderate DLB.

02

Conditions studied

  • Dementia With Lewy Bodies

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03

In context

Lewy Body Disease

231 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.

This study's enrollment of 26 is below the median of 83 across 142 interventional studies indexed under Lewy Body Disease.

Browse Lewy Body Disease studies →

Lead sponsor

Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.

Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent
  2. Capable of providing informed consent and complying with study procedures. Subjects who are unable to provide consent may use a Legally Authorized Representative (LAR)
  3. Age of 25-90 years, medically stable
  4. Clinical diagnosis of DLB according to McKeith et al (7) with both dementia MoCA≥18 and Parkinsonian defined as bradykinesia in combination with rest tremor, rigidity or both UPDRS I-III ≤ 50 and UPDRS-III between 20-40.
  5. Dementia and Parkinsonism must be present with at least one other symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD)
  6. Abnormal DaTScan
  7. Stable on Levodopa no more than 800mg daily, acetylcholinesterase inhibitors, dopamine agonists for at least 6 weeks
  8. Stable on monoamine oxidase inhibitors (MOA-B) for at least 4 weeks before enrollment
  9. Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI
  10. QTc interval 350-480 ms, inclusive
  11. Participants must be willing to undergo LP at baseline and 3 months after treatment.

Exclusion criteria

Exclusion Criteria:

  1. Medical history of liver or pancreatic disease, GI ulcers and Chron's disease, kidney, GI, or blood problems
  2. Abnormal liver function defined as AST and/or ALT > 100% the upper limit of the normal
  3. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of normal or proteinuria
  4. History of HIV, clinically significant chronic hepatitis, or other active infection
  5. hypokalemia, hypomagnesaemia, or long QT syndrome- QTc≥480 ms or concomitant drugs known to prolong the QTc interval and history of any cardiovascular disease, including myocardial infarction or cardiac failure, angina, arrhythmia
  6. History or presence of significant cardiac conditions including: cardiovascular or cerebrovascular event (e.g. myocardial infarction, unstable angina, or stroke), congestive heart failure, first, second- or third-degree atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances, any history of Torsade de Pointes.
  7. Treatment with any of the following drugs at the time of screening or the preceding 30 days, and/or planned use over the course of the trial: Treatment with Class IA or III antiarrhythmic drugs (e.g. quinidine), treatment with QT prolonging drugs (www.crediblemeds.org)- excluding SSRIs (e.g. Citalopram, Escitalopram, Paroxetine, Sertraline, Duloxetine, Trazodone, etc.), Strong CYP3A4 inhibitors (including grapefruit juice). The concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) must be avoided. Should treatment with any of these agents be required, therapy with Bosutinib should be interrupted. Anticoagulants, including Coumadin (warfarin), heparin, enoxaparin, daltiparin, xeralto, etc. St. John's Wort and the concomitant use of strong other CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) must be avoided since these agents may reduce the concentration of Bosutinib
  8. Females must not be lactating, pregnant or with possible pregnancy
  9. Clinical signs indicating syndromes other than DLB including, Alzheimer's Disease (AD) idiopathic PD, corticobasal degeneration, supranuclear gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs, early severe autonomic involvement, Babinski sign
  10. Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any active major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse
  11. Evidence of any significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal or other systemic disease or laboratory abnormality.
  12. Active neoplastic disease, history of cancer five years prior to screening, including breast cancer (history of skin melanoma or stable prostate cancer are not exclusionary)
  13. Contraindications to LP: prior lumbosacral spine surgery, severe degenerative joint disease or deformity of the spine, platelets \< 100,000, use of Coumadin/warfarin, or history of a bleeding disorder.
  14. Must not be on any immunosuppressant medications
  15. Must not be enrolled as an active participant in another clinical study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Thirty (30) participants will be recruited and randomized into 2 groups (arms) (1:1) .Fifteen (15) patients in group 1 will receive the matching placebo("sugar pill") one (1) capsule orally once daily for 3 months (90 days).

    Drug: Placebo Oral Tablet

  • Active comparator
    100 mg of Bosutinib

    Thirty (30) participants will be recruited and randomized into 2 groups (arms) (1:1) .Fifteen (15) patients in group 2 will receive the 100 mg of Bosutinib one (1) capsule orally once daily for 3 months (90 days).

    Drug: Bosutinib Oral Tablet

Interventions

  • DrugPlacebo Oral Tablet

    Fifteen (15) patients in group 1 will receive the matching placebo("sugar pill") one (1) tablet orally once daily for 3 months (90 days) .

    Also known as: Placebo

  • DrugBosutinib Oral Tablet

    Fifteen (15) patients in group 1 will receive the 100 mg of Bosutinib one (1) tablet orally once daily for 3 months (90 days) .

    Also known as: Bosutinib(Bosulif®, SKI-606, Pfizer)

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability Go/NoGo (25% Discontinuations) Will be Determined Based on Any Emergent Adverse Events.

    We will determine safety and tolerability using the occurrence of adverse events (AEs) of interest, including myelosuppression, urinary, pancreatic and hepatic disorders, QTc prolongation as per Bosutinib IB.

    Time frame: 12 weeks

Secondary outcomes

  1. Determine Changes in Absorbance Levels (ABS) in DLB Related CSF and Plasma Tyrosine Kinases

    Phospho-ABL(PanTyr) and phospho-SRC(Y416) are critical drivers in the pathogenesis of various neurodegenerative diseases. We will examine the changes in CSF and Plasma phospho-ABL(PanTyr) and phospho-SRC(Y416) absorbance (ABS) levels at baseline and 3 months. The magnitude of the absorbance is proportional to the quantity of tyrosine-phosphorylated protein.

    Time frame: Change between baseline (BSL) and Week-12

  2. Determine the Maximum Concentration (Cmax) (ng/ml) of Bosutinib in the CSF and Plasma.

    To determine the Cmax (ng/ml), we will measure Bosutinib in both the CSF and Plasma using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: 12 weeks

  3. Determine the Maximum Concentration (Cmax) (nM) of Bosutinib in the CSF and Plasma.

    To determine the Cmax (nM), we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: 12 weeks

  4. Determine the Maximum Time (Tmax) Bosutinib Peaks in CSF and Plasma.

    To determine the Tmax, we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: 12 weeks

  5. Determine the Area Under the Curve (AUC) (ng/ml*Hours) for Bosutinib in CSF and Plasma.

    To determine the AUC (ng/ml\*hours) , we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: 12 weeks

  6. Determine the Area Under the Curve (AUC) (nM*Hours) for Bosutinib in CSF and Plasma.

    To determine the AUC (nM\*hours) , we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

    Time frame: 12 weeks

  7. Changes in Dementia Lewy Body (DLB) Related CSF and Plasma Biomarkers

    We will examine the changes in CSF and Plasma Abeta40, Abeta42, total tau, ptau181 and total and oligomeric alpha-synuclein at baseline, week-12, and the change between baseline and week-12.

    Time frame: Change between baseline (BSL) and Week-12

  8. Change in Ratios in Dementia Lewy Body (DLB) Related CSF and Plasma Biomarkers

    We will examine the ratio changes in CSF and Plasma AB42 to AB40, ptau(181 )to AB42, pTau(181) to tTau, aggregated a-syn to total a-syn at baseline, 12 weeks, and between baseline and week-12.

    Time frame: 12 weeks

  9. Measure HVA and DOPAC in CSF and Plasma

    We will measure the levels of DOPAC AND Homovanillic Acid (HVA) using liquid-liquid extraction and Liquid chromatography-tandem mass spectrometry (LC-MS/MS) in CSF and plasma samples at baseline (BSL), 12 weeks, and between baseline and 12 weeks (WK12).

    Time frame: 12 weeks

07

Results

Posted Jul 10, 2026

Participant flow

Participant flow — Overall Study
MilestonePlacebo100 mg of Bosutinib
Started1313
Completed1313
Not completed00

Outcome measures

PrimarySafety and Tolerability Go/NoGo (25% Discontinuations) Will be Determined Based on Any Emergent Adverse Events.

We will determine safety and tolerability using the occurrence of adverse events (AEs) of interest, including myelosuppression, urinary, pancreatic and hepatic disorders, QTc prolongation as per Bosutinib IB.

Time frame:
12 weeks
Reported as:
Number · events
Safety and Tolerability Go/NoGo (25% Discontinuations) Will be Determined Based on Any Emergent Adverse Events.
eventsPlacebo100 mg of Bosutinib
Falls33
Pain13
Flu10
Liver Transaminases01
Post-lumbar puncture headache01
Dizziness11
Urinary incontinence01
Urinary tract infection01
Upper respiratory infection10
Lesion10
SecondaryDetermine Changes in Absorbance Levels (ABS) in DLB Related CSF and Plasma Tyrosine Kinases

Phospho-ABL(PanTyr) and phospho-SRC(Y416) are critical drivers in the pathogenesis of various neurodegenerative diseases. We will examine the changes in CSF and Plasma phospho-ABL(PanTyr) and phospho-SRC(Y416) absorbance (ABS) levels at baseline and 3 months. The magnitude of the absorbance is proportional to the quantity of tyrosine-phosphorylated protein.

Time frame:
Change between baseline (BSL) and Week-12
Reported as:
Mean · AU
Determine Changes in Absorbance Levels (ABS) in DLB Related CSF and Plasma Tyrosine Kinases
AUPlacebo100 mg of Bosutinib
Baseline CSF phospho-ABL(PanTyr)0.09 ± 0.010.10 ± 0.01
12 weeks CSF phospho-ABL(PanTyr)0.11 ± 0.010.11 ± 0.01
Change from Baseline CSFphospho-ABL(PanTyr)0.02 ± 0.010.01 ± 0.01
Baseline CSF phospho-SRC(Y416)0.06 ± 00.06 ± 0
12 weeks CSF phospho-SRC(Y416)0.08 ± 0.040.08 ± 0.03
Change from Baseline CSF phospho-SRC(Y416)0.02 ± 0.040.02 ± 0.02
Baseline Plasma phospho-ABL(PanTyr)0.08 ± 0.000.075 ± 0.010
12 weeks Plasma phospho-ABL(PanTyr)0.09 ± 0.020.102 ± 0.034
Change from Baseline Plasma phospho-ABL(PanTyr)0.01 ± 0.020.026 ± 0.033
Baseline Plasma phospho-SRC(Y416)0.066 ± 0.010.065 ± 0.011
12 weeks Plasma phospho-SRC(Y416)0.074 ± 0.020.088 ± 0.020
Change from Baseline Plasma phospho-SRC(Y416)0.008 ± 0.020.024 ± 0.019
SecondaryDetermine the Maximum Concentration (Cmax) (ng/ml) of Bosutinib in the CSF and Plasma.

To determine the Cmax (ng/ml), we will measure Bosutinib in both the CSF and Plasma using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Time frame:
12 weeks
Reported as:
Mean · ng/ml
Determine the Maximum Concentration (Cmax) (ng/ml) of Bosutinib in the CSF and Plasma.
ng/mlPlacebo100 mg of Bosutinib
Plasma Cmax0 ± 029.93 ± 10.27
CSF Cmax0 ± 00.5 ± 0.17
SecondaryDetermine the Maximum Concentration (Cmax) (nM) of Bosutinib in the CSF and Plasma.

To determine the Cmax (nM), we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Time frame:
12 weeks
Reported as:
Mean · nM
Determine the Maximum Concentration (Cmax) (nM) of Bosutinib in the CSF and Plasma.
nMPlacebo100 mg of Bosutinib
Plasma Cmax0 ± 056.43 ± 19.34
CSF Cmax0 ± 00.94 ± 0.32
SecondaryDetermine the Maximum Time (Tmax) Bosutinib Peaks in CSF and Plasma.

To determine the Tmax, we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Time frame:
12 weeks
Reported as:
Mean · hours
Determine the Maximum Time (Tmax) Bosutinib Peaks in CSF and Plasma.
hoursPlacebo100 mg of Bosutinib
Plasma Tmax0 ± 04 ± 0
CSF Tmax0 ± 03 ± 0
SecondaryDetermine the Area Under the Curve (AUC) (ng/ml*Hours) for Bosutinib in CSF and Plasma.

To determine the AUC (ng/ml\*hours) , we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Time frame:
12 weeks
Reported as:
Mean · ng/ml*hours
Determine the Area Under the Curve (AUC) (ng/ml*Hours) for Bosutinib in CSF and Plasma.
ng/ml*hoursPlacebo100 mg of Bosutinib
Plasma AUC (0-4hrs)0 ± 073.1 ± 6.63
CSF AUC (0-4hrs)0 ± 01.15 ± 0.15
SecondaryDetermine the Area Under the Curve (AUC) (nM*Hours) for Bosutinib in CSF and Plasma.

To determine the AUC (nM\*hours) , we will measure Bosutinib in both the CSF and Plasma and perform population pharmacokinetics using Liquid chromatography-tandem mass spectrometry (LC-MS/MS)

Time frame:
12 weeks
Reported as:
Mean · nM*hr
Determine the Area Under the Curve (AUC) (nM*Hours) for Bosutinib in CSF and Plasma.
nM*hrPlacebo100 mg of Bosutinib
Plasma AUC (0-4hrs)0 ± 0137.8 ± 12.5
CSF AUC (0-4hrs)0 ± 02.16 ± 0.21
SecondaryChanges in Dementia Lewy Body (DLB) Related CSF and Plasma Biomarkers

We will examine the changes in CSF and Plasma Abeta40, Abeta42, total tau, ptau181 and total and oligomeric alpha-synuclein at baseline, week-12, and the change between baseline and week-12.

Time frame:
Change between baseline (BSL) and Week-12
Reported as:
Mean · pg/ml
Changes in Dementia Lewy Body (DLB) Related CSF and Plasma Biomarkers
pg/mlPlacebo100 mg of Bosutinib
Baseline CSF AB405157 ± 1197.35089.9 ± 1460
Baseline CSF AB42508.4 ± 188.6487 ± 166.2
Baseline CSF tTau502.1 ± 173.6560.1 ± 300.8
Baseline CSF pTau(181)78.1 ± 36.767.2 ± 38.5
Baseline CSF total a-syn1347.7 ± 527.51805.2 ± 902
Baseline CSF aggregated a-syn46.6 ± 23.748.4 ± 17.3
Baseline plasma total a-syn8593.1 ± 4606.313861.9 ± 14946.9
Baseline plasma aggregated a-syn31.3 ± 16.132.4 ± 10.9
Week-12 CSF AB405419.9 ± 1319.3539.2 ± 1524
Week-12 CSF AB42513.8 ± 233.1525 ± 161.8
Week-12 CSF tTau494.5 ± 237.4476.4 ± 191
Week-12 CSF pTau(181)67.2 ± 36.766.2 ± 39.7
Week-12 CSF total a-syn1758.3 ± 1251.91488.9 ± 1050.9
Week-12 CSF aggregated a-syn71.6 ± 21.367.8 ± 13.9
Week-122 plasma total a-syn10184.3 ± 5849.517206.2 ± 12878
Week-12 plasma aggregated a-syn51.8 ± 33.245.9 ± 24.6
Change from Baseline CSF AB40263 ± 702.3309.3 ± 795
Change from Baseline CSF AB425.4 ± 106.737.9 ± 66.8
Change from Baseline CSF tTau-7.5 ± 287.9-10.3 ± 96.1
Change from Baseline CSF pTau(181)-10.9 ± 30-0.986 ± 12
Change from Baseline CSF Total a-syn55.1 ± 542-479.4 ± 691.8
Change from Baseline CSF aggregated a-syn25 ± 17.419.4 ± 20.3
Change from Baseline Plasma total a-syn1591.2 ± 5707.73344.3 ± 19774.5
Change from Baseline Plasma aggregated a-syn20.5 ± 38.312.1 ± 26.5
SecondaryChange in Ratios in Dementia Lewy Body (DLB) Related CSF and Plasma Biomarkers

We will examine the ratio changes in CSF and Plasma AB42 to AB40, ptau(181 )to AB42, pTau(181) to tTau, aggregated a-syn to total a-syn at baseline, 12 weeks, and between baseline and week-12.

Time frame:
12 weeks
Reported as:
Mean · ratio
Change in Ratios in Dementia Lewy Body (DLB) Related CSF and Plasma Biomarkers
ratioPlacebo100 mg of Bosutinib
Baseline CSF AB42/ AB400.01 ± 0.0270.10 ± 0.02
Baseline CSF pTau(181)/ AB420.18 ± 0.110.15 ± 0.11
Baseline CSF pTau(181)/ tTau0.16 ± 0.070.13 ± 0.05
Baseline CSF aggregated/ total a-syn0.04 ± 0.020.03 ± 0.03
Baseline CSF/plasma total a-synuclein0.21 ± 0.160.26 ± 0.22
Baseline CSF/plasma aggregated a-synuclein1.66 ± 0.861.47 ± 0.54
Baseline Plasma aggregated/total a-synuclein0.005 ± 0.0030.004 ± 0.003
Baseline CSF aggregated/Plasma total a-syn0.04 ± 0.020.03 ± 0.03
Baseline Plasma aggregated/CSF total a-syn0.03 ± 0.020.02 ± 0.02
Week-12 CSF AB42/ AB400.10 ± 0.030.10 ± 0.02
Week-12 CSF pTau(181)/ AB420.15 ± 0.080.14 ± 0.10
Week-12 CSF pTau(181)/ tTau0.15 ± 0.1010.14 ± 0.07
Week-12 CSF aggregated/total a-syn0.05 ± 0.030.06 ± 0.03
Week-12 CSF/plasma total a-synuclein0.24 ± 0.230.13 ± 0.12
Week-12 CSF/plasma aggregated a-synuclein1.53 ± 0.682.71 ± 2.58
Week-12 Plasma aggregated/total a-synuclein0.008 ± 0.0080.004 ± 0.003
Week-12 CSF aggregated/Plasma total a-syn0.01 ± 0.0090.006 ± 0.004
Week-12 Plasma aggregated/CSF total a-syn0.04 ± 0.030.04 ± 0.03
Change from Baseline CSF AB42/ AB400.01 ± 0.020.002 ± 0.006
Change from Baseline CSF pTau(181)/ AB42-0.03 ± 0.05-0.01 ± 0.03
Change from Baseline CSF pTau(181)/ tTau-0.01 ± 0.090.02 ± 0.08
Change from Baseline CSF aggregated/ total a-syn0.01 ± 0.030.03 ± 0.02
Change from Baseline CSF/plasma total a-synuclein0.03 ± 0.14-0.13 ± 0.24
Change from Baseline CSF/plasma aggregated a-synuclein-0.25 ± 1.411.03 ± 2.51
Change from Baseline Plasma aggregated/total a-synuclein0.003 ± 0.008-0.00009 ± 0.004
Change from Baseline CSF aggregated/Plasma total a-syn-0.25 ± 1.41-0.0006 ± 0.006
Change from Baseline Plasma aggregated/CSF total a-syn0.008 ± 0.040.01 ± 0.03
Baseline DOPAC CSF/plasma0.25 ± 0.090.33 ± 0.12
Week-12 DOPAC CSF/plasma0.25 ± 0.180.37 ± 0.12
Change from Baseline DOPAC CSF/plasma0.00017 ± 0.140.04 ± 0.11
Baseline HVA CSF/plasma1.03 ± 0.481.35 ± 0.95
Week-12 HVA CSF/plasma1.0 ± 0.811.38 ± 0.57
Change from Baseline HVA CSF/plasma-0.03 ± 0.730.03 ± 0.82
SecondaryMeasure HVA and DOPAC in CSF and Plasma

We will measure the levels of DOPAC AND Homovanillic Acid (HVA) using liquid-liquid extraction and Liquid chromatography-tandem mass spectrometry (LC-MS/MS) in CSF and plasma samples at baseline (BSL), 12 weeks, and between baseline and 12 weeks (WK12).

Time frame:
12 weeks
Reported as:
Mean · ng/ml
Measure HVA and DOPAC in CSF and Plasma
ng/mlPlacebo100 mg of Bosutinib
Baseline CSF DOPAC0.65 ± 0.310.56 ± 0.23
Baseline CSF HVA50.7 ± 27.6640.34 ± 27.58
Baseline Plasma DOPAC3.48 ± 3.192.09 ± 1.76
Baseline Plasma HVA62.93 ± 50.0834.57 ± 27.69
Week-12 CSF DOPAC0.62 ± 0.240.62 ± 0.46
Week-12 CSF HVA50.27 ± 24.6947.9 ± 54.04
Week-12 Plasma DOPAC5.10 ± 5.193.66 ± 6.74
Week-12 Plasma HVA81.7 ± 60.3941.77 ± 48.16
Change from Baseline CSF DOPAC-0.03 ± 0.190.06 ± 0.30
Change from Baseline CSF HVA-0.43 ± 15.217.56 ± 32.18
Change from Baseline Plasma DOPAC1.62 ± 3.191.74 ± 7.05
Change from Baseline Plasma HVA18.77 ± 34.599.86 ± 44.75

Adverse events

Collected over Adverse event data was collected over the course of 16 weeks for each patient.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/13 (0%)0/13 (0%)6/13 (46.2%)
100 mg of Bosutinib0/13 (0%)0/13 (0%)6/13 (46.2%)
Most frequent other events
Most frequent other events
EventPlacebo100 mg of Bosutinib
FallsGeneral disorders3/132/13
PainGeneral disorders1/132/13
FluGeneral disorders1/130/13
Liver transaminasesHepatobiliary disorders0/131/13
Post-lumbar puncture headacheNervous system disorders0/131/13
DizzinessNervous system disorders1/131/13
Urinary incontinenceRenal and urinary disorders0/131/13
Urinary tract infectionRenal and urinary disorders0/131/13
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders1/130/13
LesionsSkin and subcutaneous tissue disorders1/130/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo100 mg of BosutinibTotal
<=18 years000
Between 18 and 65 years112
>=65 years121224
Age, Continuous
Age, Continuous(years)Placebo100 mg of BosutinibTotal
Mean74.45 ± 8.2271.43 ± 7.9473 ± 8.06
Sex: Female, Male
Sex: Female, Male(Participants)Placebo100 mg of BosutinibTotal
Female011
Male131225
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo100 mg of BosutinibTotal
American Indian or Alaska Native000
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American011
White121224
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Placebo100 mg of BosutinibTotal
United States131326
08

Study locations

1 site
  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia 20007, United States
09

References and documents

Publications

  • Hebron ML, Lonskaya I, Olopade P, Selby ST, Pagan F, Moussa CE. Tyrosine Kinase Inhibition Regulates Early Systemic Immune Changes and Modulates the Neuroimmune Response in alpha-Synucleinopathy. J Clin Cell Immunol. 2014 Sep 30;5:259. doi: 10.4172/2155-9899.1000259. PubMed 25635231 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 21, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03888222
Lead sponsor
Georgetown University
Collaborators
Alzheimer's Association
Responsible party
Fernando Pagan MD (Associate Professor Of Neurology , Director of Movement Disorder Program, Medical Director of NPF COE at GUH , Fellowship Director, Georgetown University) — Principal investigator
First posted
Mar 25, 2019
Start date
Apr 23, 2019
Primary completion
Aug 27, 2021
Completion
Aug 27, 2021
Results posted
Jul 10, 2026
Last update
Jul 10, 2026

Study contacts

Fernando L Pagan, MD
principal investigator · Georgetown Univeristy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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