Alzheimers disease, Dementia with Lewy Bodies
Conditions
Interventions
Clinically diagnosed AD group:Aß and tau PET/CT
Clinically diagnosed possible and probable DLB group:Aß and tau PET/CT
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Clinical diagnosis of Alzheimer's disease (AD) or probable/possible dementia with Lewy bodies (DLB); 2)Male or female participants of childbearing potential must agree to use effective contraceptive methods during the study period (effective contraceptive methods include sterilization, intrauterine hormonal devices, condoms, oral contraceptives/contraceptive agents, abstinence, or vasectomy, etc.); 3)Participants must fully understand the purpose, nature, methods, and potential adverse reactions of the study, voluntarily participate and sign written informed consent, and be able to comply with the protocol to complete the study. Written informed consent must be signed by both the participant and the legal guardian (if the participant is unable to sign due to cognitive impairment or other limitations, the participant's signature line may be left blank with an explanation of the reason, and the guardian shall sign in the designated area indicating the reason).
Exclusion criteria
Exclusion criteria: 1)Women who are pregnant or breastfeeding; 2)Severe hepatic or renal impairment, or new-onset myocardial infarction that may be life-threatening; 3)Severe illness that makes it difficult to comply with study procedures; 4)Significant occupational exposure to ionizing radiation (e.g., >50 mSv/year) within the past 10 years; 5)Inability to undergo repeated venipuncture; 6)Contraindications to PET and/or MRI; 7)Presence of other neurological or psychiatric disorders, such as severe brain injury, stroke, or major depressive disorder; 8)Participants with confirmed cognitive impairment due to causes other than Alzheimer's disease (AD) or dementia with Lewy bodies (DLB); 9)Any other condition that, in the investigator's judgment, makes the participant unsuitable for inclusion in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall diagnostic accuracy of visual assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, PPV, NPV of visual assessment;AUC and optimal cutoff values of SUVR and Centiloid;Safety outcome;Inter-reader agreement;Correlation between imaging biomarkers and clinical scores;Differences in SUVR and Centiloid values between AD and DLB groups; | — |
Countries
China
Contacts
Public ContactChang Yanmin
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed