Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04926272
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University

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 Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024


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.




Primary Outcome Measures :
  1. standardized uptake value ratio (SUVR) [ Time Frame: 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

  2. Aβ42 in CSF [ Time Frame: 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

  3. t-tau in CSF [ Time Frame: 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

  4. p-tau in CSF [ Time Frame: 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

  5. MMSE (Mini-mental State Examination) [ Time Frame: 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

  6. MoCA (Montreal Cognitive Assessment) [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926272


Contacts
Layout table for location contacts
Contact: Weibing Miao, MD 86-0591-87981618 miaoweibing@126.com
Contact: Shaobo Yao, MD 86-0591-87981619 yaoshaobo008@163.com

Locations
Layout table for location information
China, Fujian
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350005
Contact: Weibing Miao, MD    059187981618    miaoweibing@126.com   
Contact: Shaobo Yao, MD    059187981619    yaoshaobo008@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
Layout table for additonal information
Responsible Party: Weibing Miao, PhD, Director of Nuclear Medicine Department, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier: NCT04926272    
Other Study ID Numbers: FirstAHFujian9
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders