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Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease

F

Fujian Medical University (FJMU)

Status and phase

Enrolling
Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: 18F-92

Study type

Interventional

Funder types

Other

Identifiers

NCT04926272
MRCTA, ECFAH of FMU [2021]130

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

18F-92, PET/CT
Experimental group
Description:
PET/CT perform after injecting 18F-92
Treatment:
Drug: 18F-92

Trial contacts and locations

1

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Central trial contact

Shaobo Yao, PhD

Data sourced from clinicaltrials.gov

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