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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04926272
• Other study ID #: MRCTA, ECFAH of FMU [2021]130
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2021
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Shaobo Yao, PhD
• Phone: 86-0591-87981618
• Email: yaoshaobo008[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• 18F-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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	standardized uptake value ratio (SUVR)	the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference	From right after tracer injection to 2-hours post-injection
Primary	Aß42 in CSF	Aß42 (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	Within 2 hours prior to tracer injection
Primary	t-tau in CSF	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	Within 2 hours prior to tracer injection
Primary	p-tau in CSF	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	Within 2 hours prior to tracer injection
Primary	MMSE (Mini-mental State Examination)	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	Within 2 hours prior to tracer injection
Primary	MoCA (Montreal Cognitive Assessment)	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	Within 2 hours prior to tracer injection