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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: Completed Phase 1 study of Alzheimer Disease and Mild Cognitive Impairment, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total levels of baricitinib in the CSF of participants 2 hours after 2 mg and 4 mg oral dosing of baricitinib.
Conditions Studied
Interventions
- DRUG Baricitinib
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - ALS Site - Boston
- Massachusetts General Hospital - AD Site - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2022-12-05 |
| Est. Completion | 2025-06-20 |
| Phase | Phase 1 |
What the finished NCT05189106 record still lists
NCT05189106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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
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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.
Where NCT05189106's enrollment target sits among peer trials
17 278th of 306 higher than 29 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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