ट्रायल रडार AI | ||
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क्लिनिकल ट्रायल NCT06741553 के लिए अल्जाइमर रोग, हल्का संज्ञानात्मक हानि (MCI) वर्तमान में भर्ती जारी है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab 120 बायोमार्कर-आधारित
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT06741553 एक अवलोकनात्मक चिकित्सकीय अध्ययन है जो अल्जाइमर रोग, हल्का संज्ञानात्मक हानि (MCI) से जुड़ा हुआ है। परीक्षण वर्तमान में भर्ती जारी चल रहा है। इसकी शुरुआत 28 जून 2024 को हुई थी, और इसमें कुल 120 प्रतिभागियों के नामांकन की योजना है। Second Affiliated Hospital, School of Medicine, Zhejiang University इस परीक्षण का नेतृत्व कर रहे हैं और इसके 1 जून 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 3 सितंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targe...और दिखाएँ
आधिकारिक शीर्षक
A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population
स्वास्थ्य स्थितियां
अल्जाइमर रोगहल्का संज्ञानात्मक हानि (MCI)अन्य अध्ययन आईडी
- 2024-1113
- 82371190 (अन्य अनुदान/वित्त पोषण संख्या) (National Natural Science Foundation of China)
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2024-06-28
अंतिम अद्यतन प्रकाशित
2025-09-03
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-06
नामांकन (अनुमानित)
120
अध्ययन प्रकार
अवलोकनात्मक
स्थिति
भर्ती जारी
प्रमुख शब्द
Alzheimer Disease
Lecanemab
Cognition
Amyloid-related imaging abnormalities
Lecanemab
Cognition
Amyloid-related imaging abnormalities
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
Treated Group This is an observational study. The investigators included early AD patients treated with Lecanemab, and evaluated them by plasma, magnetic resonance imaging (MRI) examination and clinical scale. The investigators observed the changes in MRI characteristics and clinical symptoms of patients after Lecanemab administration, evaluated the improvement effect of Lecanemab on cognitive function, and monitored the risk fact...और दिखाएँ | Lecanemab 10 mg/kg Lecanemab was administered 10mg/kg every two weeks. |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
CDR-SB Score | All study subjects underwent Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms. | CDR-SB scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
MMSE | All study subjects underwent Mini Mental State Examination (MMSE) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). MMSE, with total scores ranging from 0 to 30, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms. | MMSE scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
ADCs-ADL | All study subjects underwent Alzheimer's Disease Cooperative Study-Activity of Daily Life (ADCs-ADL) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 78, can be used to measure activity of daily life changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms. | ADCs-ADL scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
NPI | All study subjects underwent Neuropsychiatric Inventory (NPI) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms. | NPI scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
Aβ-PET Burden | All study subjects underwent Aβ positron emission tomography (PET) before the 1st dose (V1) ,at 12 and 18 months after treatment (V26,V39). The investigators quantified participants' Aβ burden using the average cortical standard uptake value ratio (SUVR), that is, tracer uptake in medial orbital frontal, lateral temporal, parietal, anterior cingulate, posterior cingulate, and precuneus regions divided by uptake in the cerebellar reference region. | Aβ-PET tested by baseline before the 1st dose(V1) , at 12 and 18 months after treatment (V25,V39) |
MRI | All study subjects underwent magnetic resonance imaging (MRI) before the 1st dose (V1) ,at 2, 3, 6,12 and 18 months after treatment. The scan includes T1, T2 fluid attenuated inversion recovery (FLAIR, 5 mm slice thickness), susceptibility weighted imaging (SWI, 1 mm slice thickness) and diffusion weighted imaging (DWI). The MRI scan can be used to meature the study subjects' hippocampus atrophy and white matter hyperintensities and to detect whether adverse events such as amyloid-related imaging abnormalities happen. | Time Frame: MRI tested by baseline before the 1st dose(V1) , at 2, 3, 6, 12 and 18 months after treatment (V5, V7, V14, V25, V39) |
Biospecimen | All study subjects underwent blood collection before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) for routine blood tests, liver and kidney function, plasma biomarkers, and other indicators. Among them, the APOE genotype of subjects will be tested before the 1st dose. | Blood tested by baseline before the 1st dose(V1) , at 3, 6,12 and 18 months after treatment(V7, V14, V25, V39) |
भागीदारी सहायक
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
बच्चा, वयस्क, वृद्ध वयस्क
अध्ययन के लिए पात्र लिंग
सभी
- Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;
- Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;
- Completion of APOE gene testing.
- Willingness to use Lecanemab.
- Unable to tolerate MRI scans;
- MRI showing hemorrhagic manifestations, including >4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations;
- Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding;
- With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.
Second Affiliated Hospital, School of Medicine, Zhejiang Universityअध्ययन केंद्रीय संपर्क
संपर्क: Yanxing Chen, M.D., +86 188 6840 1257, [email protected]
1 1 देशों में अध्ययन स्थान
Zhejiang
Affiliated Hospital, School of Medicine, Zhejiang University, China, Hangzhou, Zhejiang, 310009, China
Yanxing Chen, MD, संपर्क, +86 188 6840 1257, [email protected]
भर्ती जारी