Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05189106 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 1
Development phase
17
Enrollment target
2
Study locations

NCT05189106 is a Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment that has completed, run by Massachusetts General Hospital. The registered enrollment target is 17 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05189106, a Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target
2
Study locations

Study Summary

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.

Conditions Studied

Alzheimer Disease Mild Cognitive Impairment Amyotrophic Lateral Sclerosis

Interventions

  • DRUG Baricitinib

Study Locations (2)

Massachusetts

  • Massachusetts General Hospital - ALS Site - Boston
  • Massachusetts General Hospital - AD Site - Charlestown

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2022-12-05
Est. Completion 2025-06-20
Phase Phase 1

Sponsor

Massachusetts General Hospital

2,032 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05189106

The ClinicalTrials.gov registry entry for NCT05189106 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which Baricitinib is the first listed.

NCT05189106 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05189106 about?

NCT05189106 is a clinical study titled "Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial". 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 C9ORF...

What is the current status of trial NCT05189106?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2022-12-05. Estimated completion is 2025-06-20.

What conditions does trial NCT05189106 study?

This clinical trial studies the following conditions: Alzheimer Disease, Mild Cognitive Impairment, Amyotrophic Lateral Sclerosis.

What interventions are being tested in trial NCT05189106?

The interventions under investigation include: Baricitinib (DRUG).

Who is sponsoring clinical trial NCT05189106?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05189106 being conducted?

This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Alzheimer Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Alzheimer Disease

All registered trials for this condition

Mild Cognitive Impairment

All registered trials for this condition

Massachusetts

All trials with a study site in Massachusetts

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.