Your session is about to expire
← Back to Search
Baricitinib for Alzheimer's & ALS (NADALS Trial)
NADALS Trial Summary
This trial will study whether the drug baricitinib can help people with Alzheimer's, ALS, or other cognitive disorders by reducing inflammation.
NADALS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowNADALS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 3 trial • 1307 Patients • NCT01710358NADALS Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am between 18-80 years old and have been diagnosed with ALS or carry an ALS-causing gene.I have been treated with baricitinib before.I am between 55 and 90 years old and have been experiencing memory problems or have been diagnosed with a cognitive disorder.I have not had major surgery in the last 8 weeks and do not need any during the study.You have an active hepatitis B or C infection.I received my routine vaccinations at least 14 days before my study visit.I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.I or a close family member have had blood clots in the lungs or deep veins.I have active ulcerative colitis, Crohn's disease, or had a peptic ulcer in the last 5 years or after 65.To participate in the study, you must meet one of the following requirements:
- Be between 55-90 years old and have subjective cognitive decline, minor neurocognitive disorder, or major neurocognitive disorder (possible or probable AD)
- Be between 18-80 years old and have sporadic or familial ALS, or be an asymptomatic carrier of an ALS-causative mutation per CLIA-certified genetic testing results
- Have received the Recombinant Zoster Vaccine (RZV) within 4 years prior to enrollment, be fully vaccinated for COVID-19 per CDC guidelines, and have up-to-date immunization records per CDC guidelines
- Must have a study partner that can accompany you to every visit and co-sign any informed consent document
- Must be able to undergo a lumbar puncture (LP) without any medical issues that could make it difficult or dangerous
- Must be ambulatory, defined as able to walk at least within the home every day, but use of gait assistive devices or some use of a wheelchair is allowed
- Must have a life expectancy greater than 12 months in the opinion of the investigator
- Must have a certain level of cognitive function (MoCA score for AD patients and ALSFRS-R score for ALS patients)
- Cannot be taking Aducanumab for AD
- Must not be taking or be on a stable dose of any FDA approved treatment for at least 30 days or 1 cycle prior to screening for ALS or AD, respectively
- Must be able to provide informed consent and follow study procedures. If you cannot provide informed consent, your surrogate representative can provide consent and you can provide assent.I have tested positive for tuberculosis.I have severe liver or kidney problems with low kidney function.For participants with Alzheimer's disease: You need to have a MoCA score of at least 8 and have a study partner who can come with you to every visit and sign consent forms. You should not be taking any FDA-approved treatment for Alzheimer's disease, or if you are, it should be at a stable dose for at least 30 days before screening. Also, the doctor should agree that you can undergo a lumbar puncture.I have ALS, can walk at home, expect to live more than a year, and haven't changed my ALS medication in 30 days.I am currently using Aducanumab for Alzheimer's or have used it within the last 30 days. I haven't started any new experimental treatments for Alzheimer's in the last 30 days or within their half-lives. I do not use permanent assisted ventilation.Abnormal results on certain medical tests done during screening.I have had diverticulitis or a bowel perforation in the past.I am not on blood thinners that could make the trial unsafe for me.I am not currently taking strong OAT3 inhibitors or other prohibited medications.I received the Shingrix vaccine within the last 4 years.I do not have any serious or active infections.I currently have cancer or have had cancer in the past.I have no unstable health conditions besides ALS or AD in the last 6 months.
- Group 1: Baricitinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is this research currently open to recruitment?
"Confirmed. According to the information found on clinicaltrials.gov, this research project is actively searching for participants and has been since October 7th 2022 with the last update being made six days later."
How many participants has this research attracted?
"Indeed, clinicaltrials.gov displays that this research trial is actively searching for participants as of October 7th 2022 and was last updated on the 13th of October. The study aims to enrol 20 individuals from 4 distinct sites."
Is the enrollment of participants aged fifty and above being considered for this medical experiment?
"The parameters for participant selection specify that those entering the trial must be aged between 18 and 90. For patients younger than 18, 97 trials are available whereas 1349 trials are available for individuals beyond 65 years of age."
What are the typical applications of Baricitinib?
"Baricitinib is the preferred medication for hospitalised patients. Additionally, baricitinib has been proven to be effective in managing coronavirus disease 2019 (covid‑19), extracorporeal membrane oxygenation (ECMO) treatment, and rheumatoid arthritis."
What are the objectives of this research endeavor?
"The primary assessment for this study will measure CSF CCL2 Concentration at baseline, 8 weeks and 16 weeks. Secondary markers of the trial's efficacy include CSF tau Concentration (a neuronal death biomarker), IFNG protein concentration (an inflammatory marker) and CXCL10 protein levels (another indicator of inflammation). All measurements are relative to pre-treatment values."
Is it feasible for me to partake in this medical experiment?
"This randomized clinical trial is recruiting 20 individuals aged 18 to 90 with a diagnosis of amyotrophic lateral sclerosis. Subsequently, applicants must meet the following particulars: Subjective cognitive decline(SCD), Minor neurocognitive disorder(mild cognitive impairment(MCI)), Major neurocognitive disorder (potential or certain Alzheimer's disease) OR sporadic or familial ALS as outlined in the revised El Escorial criteria; Asymptomatic carriers of an ALS-causative mutation certified through CLIA genetic testing (MGH site only); CSF CCL2 levels ≥ 250 pg/mL at screening; Up-to-date immun"
What other experiments have been conducted involving Baricitinib?
"The initial research into baricitinib was conducted in 2007 at University of Nebraska Medical Center, since then there have been 44 completed clinical trials. Currently, 31 live studies are being carried out mainly within Charlestown, Florida."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger