Alzheimer's Disease
Conditions
Brief summary
Alzheimer's disease is a neurodegenerative disease. Numerous studies have reported that β-amyloid (Aβ) is an important marker for the diagnosis of AD. 18F-92 molecular probe is a novel molecularly targeted imaging agent, which can rapidly penetrate the blood-brain barrier and has high affinity and selectivity for Aβ protein. In this study, 18F-92 PET/CT was used to monitor the regional distribution and the degree of deposition in patients with Alzheimer's disease, and compared with clinical symptoms (neuropsychometry) to evaluate its application value in the diagnosis of AD.
Detailed description
Healthy volunteers as well as patients meeting Alzheimer's criteria will be recruited for this study. We will use PET/CT imaging technology to scan each participant's whole body or head and collect image data for analysis to evaluate the distribution and metabolism of 18F-92 in the subject's body. Time from drug injection to scan completion is approximately 1 hour.
Interventions
DRUG18F-92
Intravenous injection of one dose of 0.10mCi/kg(±5%) 18F-92. Each subject receive a single intravenous injection of 18F-92, and undergo PET/CT imaging within the specificed time.
Sponsors
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients or their families complain of significant memory impairment; * Objective memory impairment (e.g., tests of article identification, recall, delayed memory); * Meets Alzheimer's criteria for DSMIV and NINCDS-ADRDA; * Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up; * Signed written consent.
Exclusion criteria
* Nervous system diseases: including brain tumors, craniocerebral trauma, multiple sclerosis, epilepsy, etc.; * Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis; * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| standardized uptake value ratio (SUVR) | From right after tracer injection to 2-hours post-injection | the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference |
| Aβ42 in CSF | Within 2 hours prior to tracer injection | Aβ42 (amyloid beta isoform 42) is significantly lower in the cerebrospinal fluid of patients with Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease |
| t-tau in CSF | Within 2 hours prior to tracer injection | t-tau (total tau) is significantly increased in the cerebrospinal fluid of patients with Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease |
| p-tau in CSF | Within 2 hours prior to tracer injection | p-tau (tau phosphorylated at Thr-181) is significantly increased in the cerebrospinal fluid of patients with Alzheimer's disease and is one of the biomarkers used clinically to diagnose Alzheimer's disease |
| MMSE (Mini-mental State Examination) | Within 2 hours prior to tracer injection | The commonly used neuropsychological evaluation scale in clinical practice can comprehensively reflect the intellectual status and the degree of cognitive decline of the subjects. 30 points total, lower scores represent worse cognitive function, normal: 27-30 points; cognitive dysfunction: \< 27; mild: 21-26; moderate: 10-20; severe: 0-9 |
| MoCA (Montreal Cognitive Assessment) | Within 2 hours prior to tracer injection | A scale used clinically for cognitive function screening, with a full score of 30, ≥ 27 being normal, 18-26 being mild cognitive impairment, 10-17 being moderate, and less than 10 being severe |
Countries
China
Contacts
Primary ContactShaobo Yao, PhD
Outcome results
None listed