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Nilotinib for Lewy Body Dementia
Study Summary
This trial will evaluate if the drug Nilotinib can improve symptoms in patients with Dementia with Lewy Bodies, a condition that shares similarities with both Parkinson's disease and Alzheimer's disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You show signs of other brain conditions besides dementia with Lewy bodies, such as Parkinson's disease, corticobasal degeneration, or multiple system atrophy.You have a medical condition or abnormal test results that make it unsafe for you to take the experimental drug.You have a history of HIV, long-lasting hepatitis, or an ongoing infection that is causing health issues.Your kidneys are not working well, as shown by high levels of creatinine in your blood.You have any ongoing cancer, or had cancer within the last five years, except for certain types like melanoma or stable prostate cancer.Your MDS-UPDRS-III score is between 15 and 40 when you are on your medication, or up to 70 when you are off your medication.You are between 25 and 90 years old and in good health.You have had problems with your liver or pancreas in the past.You have a history of serious heart problems like heart attack, stroke, or heart failure, or certain heart rhythm issues.You are not taking any medications that weaken your immune system.Abnormal results from a DaTScan.Your heart's QTc interval is between 350 and 460 milliseconds.You have low levels of potassium or magnesium in your blood, or a heart condition called long QT syndrome with a specific measurement of heart activity.You are taking medications that can affect your heart rhythm, or you have a history of heart problems like heart attack, heart failure, angina, or irregular heartbeats.You have taken certain medications in the past 30 days, or plan to take them during the trial, including drugs that affect heart rhythm, strong CYP3A4 inhibitors, anticoagulants, and St. John's Wort.Your liver function tests show that your AST and/or ALT levels are more than double the normal range.You have had epilepsy, a brain injury, or a major psychiatric disorder in the past two years.You cannot participate if you had spine surgery before, have severe spine joint problems, low platelet count, take Coumadin/warfarin, or have a history of bleeding disorder.You have been diagnosed with dementia with Lewy bodies (DLB) and also show signs of Parkinson's disease such as slow movements, tremors, or stiffness. You must also have at least one other symptom like changes in alertness, seeing things that aren't there, or acting out dreams during sleep.You are at a specific stage of Parkinson's disease, between stages 2.5 and 3 according to the Hoehn and Yahr scale.You have been taking MAO-B inhibitors like Selegeline or rasagiline for at least 4 weeks before the study and during treatment with Nilotinib.
- Group 1: Placebo
- Group 2: 200 mg Nilotinib
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research include elderly individuals as participants?
"The protocol for this study specifies that participants must be aged 25 or older and no more than 90 years old."
Is there presently an opportunity to join this experiment?
"Affirmative. The information available on clinicaltrials.gov implies that this experiment is presently enrolling volunteers. It was first released on July 1, 2019 and its details were most recently updated on May 2, 2022. A total of 60 participants are being registered at a single site."
Who qualifies to participate in this medical experiment?
"This medical trial is looking to recruit 60 participants aged between 25 and 90 that have been clinically diagnosed with dementia. The enrolled patients must be able to comprehend the study's procedures, provide informed consent or appoint a Legally Authorized Representative (LAR), demonstrate relatively mild Parkinsonian symptoms according to UPDRS scores of I-III less than 50/UPDRS III 15-40 on state, present one additional symptom such as fluctuation, visual hallucinations or REM sleep behavioral disorder (RBD), possess an abnormal DaTScan result and be medically stable. Furthermore, it is required that those interested in enrolling not take monoamine oxid"
How does this experiment compare to previous precedents in its field?
"Since 2008, 200 mg Nilotinib has been explored in numerous clinical trials. The inaugural study was funded by Novartis Pharmaceuticals and included 34 participants; the trial concluded with Phase 4 drug approval for this dosage of nitlotinib. At present, 35 disparate experiments are being conducted on its efficacy across 42 nations and 566 cities."
How many persons have enrolled in this research endeavor?
"Affirmative, according to the information hosted on clinicaltrials.gov this trial is actively recruiting patients. This medical study was initially posted July 1st 2019 and last updated May 2nd 2022; a total of 60 participants are needed across one centre for enrolment."
Has any research been carried out concerning the efficacy of 200 mg Nilotinib?
"Presently, 35 clinical trials for 200 mg Nilotinib are underway; 6 of them being in the advanced Phase 3 stage. The epicentre for this research appears to be Fukuoka city, with 1548 centres operating studies on the medication globally."
How much Nilotinib is permissible for therapeutic use without posing a risk?
"Nilotinib has been evaluated in a Phase 2 trial, so our team at Power considered the safety of 200 mg to be moderately safe and scored it as a 2."
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