Baricitinib for Alzheimer's & ALS

(NADALS Trial)

Recruiting at3 trial locations

Overseen by Mark W Albers, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests baricitinib, a pill taken daily, in people with early signs of Alzheimer's or ALS, or those at risk. The goal is to see if it can reduce harmful inflammation in the brain. Participants will take the medication for several months to check if it reaches the brain and lowers inflammation. Baricitinib is used for the treatment of rheumatoid arthritis and has shown promising preliminary data for moderate-to-severe atopic dermatitis.

Research Team

Mark W Albers, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Adults aged 55-90 with cognitive issues like Alzheimer's or mild impairment, and those aged 18-80 with ALS or carrying an ALS-related gene. Participants must have up-to-date vaccinations including Shingrix and COVID-19, be able to consent, and for those with AD, a MoCA score ≥8 plus a study partner is required. For ALS patients: stable on FDA treatments if any, able to walk at home daily, and life expectancy over 12 months.

Inclusion Criteria

I am between 18-80 years old and have been diagnosed with ALS or carry an ALS-causing gene.

I am between 55 and 90 years old and have been experiencing memory problems or have been diagnosed with a cognitive disorder.

Up-to-date immunization records per CDC guidelines

Exclusion Criteria

I have been treated with baricitinib before.

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.

Treatment Details

Interventions

• Baricitinib (Janus Kinase (JAK) Inhibitor)

Trial Overview The trial tests baricitinib in participants with various neurodegenerative conditions over 24 weeks without using a placebo. It starts at a lower dose for the first eight weeks before doubling. The goal is to see if it can reach therapeutic levels in the brain/spinal fluid and reduce inflammation markers linked to these diseases.

Participant Groups

Group I: Baricitinib Experimental Treatment 1 Intervention

Baricitinib 2mg administered by mouth once daily for the first 8 weeks, followed by baricitinib 4mg administered by mouth once daily for 16 weeks.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School