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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: 18F-92

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shaobo Yao, PhD; Phone Number: 86-0591-87981618; Email: yaoshaobo008@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
      • Contact: Shaobo Yao, PhD; Phone Number: 059187981618; Email: yaoshaobo008@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-92, PET/CT; PET/CT perform after injecting 18F-92	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Aβ42 in CSF	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	Within 2 hours prior to tracer injection
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
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
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: June 7, 2021
• First Submitted That Met QC Criteria: June 12, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: MRCTA, ECFAH of FMU [2021]130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No