Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05189106
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib — DRUG
    Each participant will be treated with open-label baricitinib for 24 weeks. Participants will receive 2 mg baricitinib by mouth daily for the first 8 weeks and 4 mg baricitinib by mouth daily for the remaining 16 weeks.

Study Details

This is an open-label, biomarker-driven basket trial of baricitinib in people with subjective cognitive disorder, mild cognitive impairment, Alzheimer's disease (AD), Amyotrophic lateral sclerosis (ALS), or asymptomatic carriers of an ALS-related gene, such as a hexanucleotide expansion in the C9ORF72 gene, with evidence of abnormal inflammatory signaling in cerebrospinal fluid (CSF) at baseline. Each participant will be treated with baricitinib for 24 weeks; no placebo will be given. Participants will receive baricitinib 2 mg per day by mouth for the first 8 weeks and baricitinib 4 mg per day by mouth for the remaining 16 weeks. This proof of concept trial will ascertain whether baricitinib at 2 mg per day, 4 mg per day, or both reaches therapeutic levels in the CSF and suppresses inflammatory biomarkers associated with type I interferon signaling among the study participants.

Key Dates

Start date
Dec 5, 2022
Status verified
May 2025
Primary completion
Apr 24, 2025
Completion
Jun 20, 2025

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

CSF Concentration of baricitinib [ Time Frame: Measured at baseline, 8 weeks and 16 weeks, results reported at the completion of the study ]

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital - ALS SiteBostonMassachusetts02129-
Massachusetts General Hospital - AD SiteCharlestownMassachusetts02129-

Find similar trials in Boston, MA

By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Massachusetts General Hospital - ALS Site· Boston, MAMassachusetts General Hospital - AD Site· Charlestown, MA

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