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

Primary Purpose

Alzheimer's Disease

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

18F-92

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-92, PET/CT

Arm Description

PET/CT perform after injecting 18F-92

Outcomes

Primary Outcome Measures

standardized uptake value ratio (SUVR)

the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04926272

First Posted

June 7, 2021

Last Updated

November 23, 2021

Sponsor

First Affiliated Hospital of Fujian Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04926272

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Fujian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

18F-92, PET/CT

Arm Type

Experimental

Arm Description

PET/CT perform after injecting 18F-92

Intervention Type

Drug

Intervention Name(s)

18F-92

Intervention Description

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 Measure Information:

Title

standardized uptake value ratio (SUVR)

Description

the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference

Time Frame

From right after tracer injection to 2-hours post-injection

Title

Aβ42 in CSF

Description

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

Time Frame