Early Alzheimers disease
Conditions
Interventions
Single-arm study:None
Sponsors
RUIJIN-HAINAN HOSPITAL SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE(Hainan Boao Research Hospital)
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.AD source MCI (medium probability): Meet the core clinical criteria for AD source MCI (medium probability) of the National Institute on Aging - Alzheimer's Association (NIA - AA) in 2011. At screening and baseline, the CDR overall score is 0.5 points, and the CDR memory score is 0.5 points or higher. Have a history of gradually onset and slowly progressing subjective memory decline for at least one year or more during the screening period; must be confirmed by family members or caregivers. 2.Mild AD Dementia: Meets the core clinical criteria for possible AD dementia according to NIA-AA 2011. At screening and baseline, the CDR global score is 0.5 - 1.0, and the CDR memory score is 0.5 or higher. 3.Key inclusion criteria that all subjects must meet: Positive for cerebral amyloidosis as shown by amyloid PET scan. Male or female subjects aged >= 50 years and <= 90 years at the time of informed consent. 8. Have a designated caregiver accompany them during each follow - up visit. 9. Provide written informed consent. If, in the opinion of the investigator, the subject lacks the capacity to give informed consent, consent should be obtained according to local laws, regulations and customs, and written informed consent should be obtained from the legal representative (the definition of legal representation and the capacity to consent should be determined according to applicable local laws and regulations). Be willing and able to comply with all aspects of the protocol.
Exclusion criteria
Exclusion criteria: 1.Head MRI and SWI sequence examination: Excluded. Note: More than 4 microbleeds (defined as a maximum diameter <= 10 mm); 2.a single hemorrhage with a maximum diameter exceeding 10 mm; 3.evidence of cortical hemosiderin deposition; 4.evidence of vasogenic edema; 5.evidence of cerebral contusion, encephalomalacia, vascular malformation or infectious lesions; 6.evidence of multiple lacunar infarctions or strokes involving major vascular regions, severe small vessel disease or severe white matter lesions; 7.intracranial space-occupying lesions, or brain tumors (lesions diagnosed as meningioma or arachnoid cyst with a maximum diameter less than 1 cm do not need to be excluded).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Standard Uptake Value Ratio (SUVR) of Aß-PET compared to baseline;Change from baseline in Centiloid results; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in CDR-SB relative to baseline at 3?6 and 12 months;Change in Zarit Burden of Care relative to baseline at 3?6 and 12 months;Change in MMSE from baseline at 3?6 and 12 months;CDR assesses the proportion of patients who progress to the next stage of disease within 12 months;Change from baseline in ADCS MCI-ADL at 3?6 and 12 months;Change in NPI relative to baseline at 3?6 and 12 months;Change in ADAS-Cog14 from baseline at 3?6 and 12 months; | — |
Countries
China
Contacts
Public ContactJun Liu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed