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Die klinische Studie NCT06883019 für Alzheimer-Krankheit ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
Lecanemab for Early Onset Familial Alzheimer's Disease 114 Beobachtend
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Die klinische Studie NCT06883019 ist eine beobachtungsstudie zur Untersuchung von Alzheimer-Krankheit und hat den Status offene rekrutierung. Die Studie startete am 13. März 2025 und soll 114 Teilnehmer aufnehmen. Durchgeführt von RenJi Hospital ist der Abschluss für 31. August 2027 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 19. März 2025 aktualisiert.
Kurzbeschreibung
The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study...Mehr anzeigen
Offizieller Titel
A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease
Erkrankungen
Alzheimer-KrankheitWeitere Studien-IDs
- LEOFAD-01
NCT-Nummer
Studienbeginn (tatsächlich)
2025-03-13
Zuletzt aktualisiert
2025-03-19
Studienende (vorauss.)
2027-08-31
Geplante Rekrutierung
114
Studientyp
Beobachtungsstudie
Status
Offene Rekrutierung
Stichwörter
Alzheimer Disease
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Chang of CDR-SB score | CDR-SB, clinical dementia rating-sum of boxes | baseline, 9 month, 18 month |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Change of amyloid burden | AV45-PET | baseline, 9 month, 18 month |
Change of ADAS-cog score | ADAS-cog, the Alzheimer's Disease Assessment Scale-Cognitive Subscale | baseline, 9 month, 18 month |
Change of ADCS-ADL score | ADCS-ADL, the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL) | baseline, 9 month, 18 month |
Change of MoCA score | MoCA, the Montreal Cognitive Assessment | baseline, 9 month, 18 month |
Change of BNT score | BNT, the Boston Naming Test | baseline, 9 month, 18 month |
Change of TMT score | TMT, the trail making test | baseline, 9 month, 18 month |
Change of HAMA and HAMD score | HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale | baseline, 9 month, 18 month |
Change of biomarkers | p-tau181, p-tau217, Aβ40, Aβ42 , pEAβ3-42, GFAP, NFL, TRPC6 ( blood, urine, feces, gingival crevicular fluid, cerebrospinal fluid) | baseline, 9 month, 18 month |
Positron emission tomography (PET) | Other PET including FDG-PET, Tau-PET, TSPO-PET, SV2A-PET, exendin-4 (GLP-1R)-PET, colinergic receptor probe (ASEM) PET | baseline, 9 month, 18 month |
Change of structural MRI | 3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI) | baseline, 9 month, 18 month |
Change of functional MRI | Blood oxygenation level dependent (BOLD) imaging | baseline, 9 month, 18 month |
Change of magnetic susceptibility | Quantitative susceptibility mapping (QSM) imaging | baseline, 9 month, 18 month |
Change of perfusion imaging | Arterial spin labeling (ASL) imaging | baseline, 9 month, 18 month |
Whole Genome Sequencing | baseline | |
Change of speech information | Speech recording of Cookie-theft description task, using self-developed ASR speech analysis software (China software copyright number: 2016RS164680) for speech analysis | baseline, 9 month, 18 month |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender.
- Diagnosis of Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Must meet the clinical diagnostic criteria for AD-related MCI and mild AD as defined by the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011); confirmed Aβ positivity through Aβ-PET/CT, Aβ-PET/MRI, or cerebrospinal fluid testing.
- MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5
- No significant signs found in the neurological examination
- Participants must be capable of completing cognitive assessments and other tests.
- Informed consent must be obtained from the participants and their legal guardians, with a dated signature, prior to any operations or tests related to the protocol, committing to comply with the research procedures and cooperate throughout the study process.
- Cognitive decline caused by other reasons: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (drugs, alcohol, CO, etc.), significant systemic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumor), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiencies or any other reasons.
- Patients with other unstable diseases, or those who have had a stroke or transient ischemic attack, bleeding disorders, or seizures within the previous 12 months.
- Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium.
- Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses.
- Exclusion of cerebral amyloid angiopathy-related inflammation/β-amyloid-related cerebral vasculitis (CAAri/ABRA).
- Presence of uncorrectable visual or auditory impairments that prevent completion of relevant assessments or scales.
- Patients who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants.
- MRI findings showing more than four microhemorrhages (diameter < 10 mm), evidence of surface iron deposition, vascular edema, diffuse white matter disease, multiple lacunar strokes, or any strokes involving major vascular regions. Presence of evidence of cerebral contusions, brain softening, cerebral aneurysms, or other vascular malformations, central nervous system (CNS) infections, as well as brain tumors other than meningiomas or arachnoid cysts.
- Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders.
- Pregnant or lactating women.
- Patients deemed unsuitable for use by clinicians apart from the exclusion criteria listed above.
- Patients with severe allergies to lecanemab or any excipients of this product.
RenJi HospitalVerantwortliche Partei
Wang Gang, Hauptprüfer, Professor, RenJi Hospital
Zentrale Studienkontakte
Kontakt: Jinwen Xiao, +86 13917310784, [email protected]
15 Studienstandorte in 1 Ländern
China
Xuanwu Hospital, Capital Medical University, Beijing, China, China
Cuibai Wei, Kontakt, +86 13910076457, [email protected]
Offene Rekrutierung
The Second Affiliated Hospital of Guangzhou Medical University, Guangdong, China, China
Jun Liu, Kontakt, +86 13609794537, [email protected]
Offene Rekrutierung
The Affiliated Hospital of Guizhou Medical University, Guizhou, China, China
Dian He, Kontakt, +86 15285948199, [email protected]
Offene Rekrutierung
Nanjing Brain Hospital, Jiangsu, China, China
Weiguo Liu, Kontakt, +86 13914725569, [email protected]
Offene Rekrutierung
Nanjing Drum Tower Hospital, Jiangsu, China, China
Hui Zhao, Kontakt, +86 13605140127, [email protected]
Offene Rekrutierung
Nantong First People's Hospital, Jiangsu, China, China
Xiangyang Zhu, Kontakt, +86 13962978278, [email protected]
Offene Rekrutierung
Huadong Hospital, Fudan University, Shanghai, China, China
Wenshi Wei, Kontakt, [email protected]
Offene Rekrutierung
Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, China
Jinwen Xiao, Kontakt, +86 13917310784, [email protected]
Offene Rekrutierung
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, China
Rujing Ren, Kontakt, +86 13917771617, [email protected]
Offene Rekrutierung
Shanghai Mental Health Center, Shanghai, China, China
Xia Li, Kontakt, +86 13774272543, [email protected]
Offene Rekrutierung
West China Hospital of Sichuan University, Sichuan, China, China
Qin Chen, Kontakt, +86 18980606301, [email protected]
Offene Rekrutierung
Tianjin Medical University General Hospital, Tianjin, China, China
Nan Zhang, Kontakt, +86 22 6036 2255, [email protected]
Offene Rekrutierung
Jinhua Central Hospital, Zhejiang, China, China
Xiaoling Pan, Kontakt, +86 15167966680, [email protected]
Offene Rekrutierung
Ningbo Second Hospital, Zhejiang, China, China
Weinv Fan, Kontakt, +86 13685701750, [email protected]
Offene Rekrutierung
The First Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang, China, China
Guoping Peng, Kontakt, +86 13588150613, [email protected]
Offene Rekrutierung