NCT06883019Toboroz
Lecanemab for Early Onset Familial Alzheimer's Disease
A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. márc. 19. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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 will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 114 (tervezett)
- Első benyújtás
- 2025. márc. 12.
- Kezdés
- 2025. márc. 13.
- Elsődleges befejezés
- 2027. jún. 30.
- Fő szponzor
- RenJi Hospital
- Betegségek
- Alzheimer-kór
- NCT-szám
- NCT06883019
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 114
- 2025. márc. 13. és az elsődleges befejezés (2027. jún. 30.) között
- 15 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 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 who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants.
- Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders.
Más betegség
- 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 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.
- 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 with severe allergies to lecanemab or any excipients of this product.
Egyéb
- 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.
- Pregnant or lactating women.
- Patients deemed unsuitable for use by clinicians apart from the exclusion criteria listed above.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak
Helyszínek (15)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Beijing | Kína | Toboroz |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangdong | Kína | Toboroz |
| The Affiliated Hospital of Guizhou Medical University | Guizhou | Kína | Toboroz |
| Nanjing Drum Tower Hospital | Jiangsu | Kína | Toboroz |
| Nanjing Brain Hospital | Jiangsu | Kína | Toboroz |
| Nantong First People's Hospital | Jiangsu | Kína | Toboroz |
| Huadong Hospital, Fudan University | Shanghai | Kína | Toboroz |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Kína | Toboroz |
| Shanghai Mental Health Center | Shanghai | Kína | Toboroz |
| Renji Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | Kína | Toboroz |
| West China Hospital of Sichuan University | Sichuan | Kína | Toboroz |
| Tianjin Medical University General Hospital | Tianjin | Kína | Toboroz |
| Ningbo Second Hospital | Zhejiang | Kína | Toboroz |
| Jinhua Central Hospital | Zhejiang | Kína | Toboroz |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Zhejiang | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.