Alzheimer's DiseasePhase 2NCT04926272
Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease
A Phase 2 study testing 18F-92 in people with Alzheimer's Disease, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- 18F-92
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Shaobo Yao, PhD, 059187981618, yaoshaobo008@163.com
About this study
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.
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- 18F-92
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-92Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-92, PET/CT | Experimental | PET/CT perform after injecting 18F-92 Receives: Drug: 18F-92 |
What is being measured
The primary outcome is the main question the study is designed to answer.
standardized uptake value ratio (SUVR)
the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 2 hours prior to tracer injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaobo Yao, PhD, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926272
- Sponsor's protocol ID
- MRCTA, ECFAH of FMU [2021]130
- Status last verified
- Nov 2021
- First submitted
- 7 Jun 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amyloid-beta PET Imaging With 18F-92 in Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04926272
- Acronym / sponsor ID
- MRCTA, ECFAH of FMU [2021]130
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-92, PET/CT | Experimental | Drug: 18F-92PET/CT perform after injecting 18F-92 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-92Intravenous 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. | Drug | 18F-92, PET/CT |
Primary outcome
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-92 in people with Alzheimer's Disease, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaobo Yao, PhD (86-0591-87981618, yaoshaobo008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
standardized uptake value ratio (SUVR) (time frame: From right after tracer injection to 2-hours post-injection). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.