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

Sponsor

First Affiliated Hospital of Fujian Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04926272

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: 18F-92	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350005

Sponsors and Collaborators

First Affiliated Hospital of Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shaobo Yao, PhD, Director of Nuclear Medicine Department, First Affiliated Hospital of Fujian Medical University

ClinicalTrials.gov Identifier:

NCT04926272

Other Study ID Numbers:

MRCTA, ECFAH of FMU [2021]130

First Posted:

Jun 15, 2021

Last Update Posted:

Dec 6, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Dec 6, 2021