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

NCT04926272 | Unknown Phase 2

• 1 other identifier: MRCTA, ECFAH of FMU [2021]130
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

18F-92, PET/CT

EXPERIMENTAL

PET/CT perform after injecting 18F-92

Drug: 18F-92

Interventions

18F-92 DRUG

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.

18F-92, PET/CT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Shaobo Yao, PhD

CONTACT

86-0591-87981618; yaoshaobo008@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 15, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 6, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)