Alzheimers disease
Conditions
Interventions
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of onset=21 or MoCA>=17 or CDR=0.5; 4. No obvious signs on neurological examination; 5. Subjects are capable of completing cognitive ability measurements and other tests; 6. Before implementing any protocol-related operations or examinations, a dated informed consent form signed by the subject and his or her legal guardian must be obtained to commit to complying with the research procedures and cooperating with the implementation of the whole process of the study.
Exclusion criteria
Exclusion criteria: 1.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. 2.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. 3.Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium. 4.Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses. 5.Exclusion of cerebral amyloid angiopathy-related inflammation/ß-amyloid-related cerebral vasculitis (CAAri/ABRA). 6.Presence of uncorrectable visual or auditory impairments that prevent completion of relevant assessments or scales. 7.Patients who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants. 8.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. 9.Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders. 10.Pregnant or lactating women. 11.Patients deemed unsuitable for use by clinicians apart from the exclusion criteria listed above. 12.Patients with severe allergies to luncantanib or any excipients of this product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in cognitive scale CDR-SB; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in brain amyloid burden;Change from baseline in the cognitive scale ADAS-cog;Change from baseline in Alzheimer's Disease-Related Life Capacity Scale;Change from baseline in biomarkers;Change from baseline in other cognitive scales;Change from baseline in other PETs;Whole Genome Sequencing;Change from baseline in multimodal magnetic resonance;Incidence of amyloid-related imaging abnormalities-edema (ARIA-E).;Amyloid-related imaging abnormalities - hemosiderin deposition (ARIA-H) Incidence;Incidence of hypersensitivity and infusion reactions; | — |
Countries
China
Contacts
Public ContactGang Wang; Jie Ligeng
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed