Neurodegenerative Alzheimer's Disease and Amyotrophic Lateral Sclerosis (NADALS) Basket Trial
第1/2相
完了
NCT05189106
| 対象疾患 | Amyotrophic Lateral Sclerosis, Alzheimer Disease, Mild Cognitive Impairment |
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| 相 | 第1/2相 |
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| スポンサー | Massachusetts General Hospital |
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| ステータス | 完了 |
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| 参加者数 | 17 名 |
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| 介入（薬剤） | Baricitinib |
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| 開始日 | 2022年12月5日 |
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| 完了日 | 2025年4月24日 |
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| 結果公開日 | 2026年6月30日 |
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概要
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.
CSF Concentration of Baricitinib
Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study. · nmol/L
| Participants With Alzheimer's Disease (AD) | 1.244 ± 0.301 nmol/L |
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| Participants With Amyotrophic Lateral Sclerosis (ALS) | 1.748 ± 0.282 nmol/L |
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| Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene | 0.460 ± 0.797 nmol/L |
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| Participants With Alzheimer's Disease (AD) | 2.469 ± 0.464 nmol/L |
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| Participants With Amyotrophic Lateral Sclerosis (ALS) | 3.804 ± 0.489 nmol/L |
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| Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene | 1.965 ± 1.228 nmol/L |
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CSF CCL2 Concentration
Measured at baseline, 8 weeks from baseline, and 16 weeks from baseline. Results reported at the completion of the study. · pg/mL
| Participants With Alzheimer's Disease (AD) | 417.640 pg/mL |
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| Participants With Amyotrophic Lateral Sclerosis (ALS) | 465.868 pg/mL |
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| Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene | 501.728 pg/mL |
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| Participants With Alzheimer's Disease (AD) | 407.202 pg/mL |
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| Participants With Amyotrophic Lateral Sclerosis (ALS) | 473.487 pg/mL |
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| Participants That Are an Asymptomatic Gene Carrier (AGC) for an ALS-causative Gene | 503.127 pg/mL |
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