Alzheimer DiseaseNCT06445582
SV2A-PET/CT and PET/MRI Combined Clinical Criteria Score in the Diagnosis of Early Cognitive Alteration
An observational study of Alzheimer Disease, run by Anhui Provincial Hospital.
Trial summary
Using SV2A-PET to character a cohort of patients with early cognitive impairment using the novel synaptic probe 18F-labeled difluoro-analog of UCB-J（also known as 18F-SDM-8） Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- [18F]SDM-8
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2025
- Phase
- Observational
- 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
Study population: This study is a single-center prospective exploratory clinical trial, and given this, it is proposed to initially enroll only 80 evaluable subjects (including 40 patients with ALZHEIMER'S DISEASE, 30 patients with MILD COGNITIVE DISABILITY, and 10 age-sex matched non-ALZHEIMER 'S DISEASE controls), each subject underwent 18F-SDM-8 PET/CT imaging, the ability of the tracer to bind to SV2A in the brain as well as non-specific binding, and correlation analysis with changes in relevant clinical indicators to assess the safety and diagnostic efficacy of the tracer.
Who may be able to join
- AD Group
- All diagnostic criteria for AD patients met the National Institute of Neurological Speech-Language Disorders Stroke Institute and Alzheimer's Disease and Related Disorders Association criteria;
- Comply with the American Psychiatric Association Diagnostic and Statistical Workbook of Mental Disorders, 5th edition (DSMIV);
- All subjects were unconscious and could be accompanied by behavioral and psychiatric abnormalities. Subjects who meet the above criteria are eligible for enrollment.
- Those who understand the process of this clinical trial and sign the informed consent form (in addition, non-AD volunteers will be recruited through verbal dissemination and posting of paper advertisements to serve as the non-AD control group, and the final control group will be screened by the clinician and consist of healthy people of similar age and gender).
- MCI Group
Show all 12Show fewer
- Concerns about cognitive changes, and concerns about finding changes in comparison with one's prior level may originate from the patient himself or herself, from an informed person, or from an experienced specialist;
- Impairment of one or more cognitive areas, primarily memory, executive function, attention, language, and visuospatial function;
- Maintaining independence in daily living, there can be minor impairment in complex instrumental daily abilities;
- Absence of dementia, mild disease, and no evidence of serious impairment of social or occupational abilities;
- Presence of one of the Aβ class biomarkers and/ neuronal damage class markers detected by imaging, cerebrospinal fluid;
- All subjects and their guardians give informed consent to the study and sign the informed consent form;
Who cannot join
- With confirmed cerebrovascular disease, the presence of multiple or extensive cerebral infarcts;
- Other types of dementia: Parkinson's disease dementia, vascular dementia, frontotemporal lobe dementia, dementia with Lewy bodies;
- Sudden onset or stroke-like episodes;
- Early onset of focal neurological symptoms, such as hemiparesis, computational deficits, ataxia, or sensory loss;
- Seizures or gait abnormalities early in the onset of the disease;
- Evidence of drug applications that cause significant effects on cognitive function;
Show all 10Show fewer
- Those who are allergic to alcohol;
- Persons with alcohol allergy; (ix) Persons with left-handedness; (x) Persons with left-handedness;
- Those with claustrophobia or other reasons for not being able to cooperate with the examination;
- Those with serious heart, liver, lung, kidney and other organ diseases, meeting the above conditions were excluded from the group.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Synaptic Vesicle Glycoprotein 2A-PET/CT and PET/MRI Combined Clinical Criteria Score in the Diagnosis of Early Cognitive Alteration
Using SV2A-PET to character a cohort of patients with early cognitive impairment using the novel synaptic probe 18F-labeled difluoro-analog of UCB-J（also known as 18F-SDM-8）
Read the detailed description
A community-based population (Han Chinese) in Hefei, China, based on the CANDI cohort；Single-center prospective case-control study；The projected enrollment population is 80; 40 patients with Alzheimer's Disease（AD）, 30 patients with Mild Cognitive Impairment（MCI）; 10 healthy controls. Diagnostic experiments and predictive prognostic experiments with new probes.
- Conditions
- Alzheimer Disease
- Being tested
- [18F]SDM-8
- Keywords
- Molecular Imaging；, Positron Emission Tomography Computed Tomography；, SV2A protein, human
- 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]SDM-8Diagnostic test
synaptic vesicle glycoprotein 2 A（SV2A）PET tracer [18F]SDM-8
| Study group | Role | What they receive |
|---|---|---|
| CANDI | China Aging and Neurodegenerative Initiative Receives: Diagnostic Test: [18F]SDM-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVR（Standardized Uptake Value Ratio）
Standardized semi-quantitative values of SUVR for each brain region of the cerebral cortex；Standardized Uptake Value ratio (SUVr) is a metric used to evaluate the results of PET scans of the brain. It is a measure of the extent of abnormal metabolism or abnormal deposits in a brain region by comparing the uptake value of a specific brain region to the uptake values of neighboring regions.
SUVr is calculated as follows:
- first, a reference region is selected, usually an adjacent region of healthy tissue that is unaffected by disease.
- then, the uptake value for the region of interest (e.g., the brain region), denoted as SUV, is calculated.
- next, the average uptake value of the reference region, denoted as SUVref, is calculated.
- finally, the SUVr is calculated, obtained by dividing the SUV of the region of interest by the SUVref of the reference region.
Measured: 1year
Secondary outcomes (1)
AUC（Area under the curve）of SUVR
AUC is defined as the area under the ROC curve enclosed with the axes. ROC (receiver operating characteristic curve) receiver operating characteristic curve, is invented by electronic engineers and radar engineers in World War II used to detect enemy carriers (aircraft, ships) on the battlefield indicators, belongs to the signal detection theory.
The SV2A SUVR calculation was performed using the reference brain region method described above, and the AUC was used to measure the ability of the SUVR to classify the AD disease spectrum versus healthy controls, and its correlation with clinical scale scores was analyzed.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qiang Xie, PhD, Principal investigator, University of Sience and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445582
- Sponsor's protocol ID
- 2023_ky_390
- Status last verified
- Jun 2024
- First submitted
- 22 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stockburger C, Miano D, Baeumlisberger M, Pallas T, Arrey TN, Karas M, Friedland K, Muller WE. A Mitochondrial Role of SV2a Protein in Aging and Alzheimer's Disease: Studies with Levetiracetam. J Alzheimers Dis. 2016;50(1):201-15. doi: 10.3233/JAD-150687.
PubMed 26639968Bajjalieh SM, Frantz GD, Weimann JM, McConnell SK, Scheller RH. Differential expression of synaptic vesicle protein 2 (SV2) isoforms. J Neurosci. 1994 Sep;14(9):5223-35. doi: 10.1523/JNEUROSCI.14-09-05223.1994.
PubMed 8083732Spurrier J, Nicholson L, Fang XT, Stoner AJ, Toyonaga T, Holden D, Siegert TR, Laird W, Allnutt MA, Chiasseu M, Brody AH, Takahashi H, Nies SH, Perez-Canamas A, Sadasivam P, Lee S, Li S, Zhang L, Huang YH, Carson RE, Cai Z, Strittmatter SM. Reversal of synapse loss in Alzheimer mouse models by targeting mGluR5 to prevent synaptic tagging by C1Q. Sci Transl Med. 2022 Jun;14(647):eabi8593. doi: 10.1126/scitranslmed.abi8593. Epub 2022 Jun 1.
PubMed 35648810Nabulsi NB, Mercier J, Holden D, Carre S, Najafzadeh S, Vandergeten MC, Lin SF, Deo A, Price N, Wood M, Lara-Jaime T, Montel F, Laruelle M, Carson RE, Hannestad J, Huang Y. Synthesis and Preclinical Evaluation of 11C-UCB-J as a PET Tracer for Imaging the Synaptic Vesicle Glycoprotein 2A in the Brain. J Nucl Med. 2016 May;57(5):777-84. doi: 10.2967/jnumed.115.168179. Epub 2016 Feb 4.
PubMed 26848175Naganawa M, Li S, Nabulsi N, Henry S, Zheng MQ, Pracitto R, Cai Z, Gao H, Kapinos M, Labaree D, Matuskey D, Huang Y, Carson RE. First-in-Human Evaluation of 18F-SynVesT-1, a Radioligand for PET Imaging of Synaptic Vesicle Glycoprotein 2A. J Nucl Med. 2021 Apr;62(4):561-567. doi: 10.2967/jnumed.120.249144. Epub 2020 Aug 28.
PubMed 32859701Li S, Cai Z, Wu X, Holden D, Pracitto R, Kapinos M, Gao H, Labaree D, Nabulsi N, Carson RE, Huang Y. Synthesis and in Vivo Evaluation of a Novel PET Radiotracer for Imaging of Synaptic Vesicle Glycoprotein 2A (SV2A) in Nonhuman Primates. ACS Chem Neurosci. 2019 Mar 20;10(3):1544-1554. doi: 10.1021/acschemneuro.8b00526. Epub 2018 Nov 16.
PubMed 30396272Chen MK, Mecca AP, Naganawa M, Finnema SJ, Toyonaga T, Lin SF, Najafzadeh S, Ropchan J, Lu Y, McDonald JW, Michalak HR, Nabulsi NB, Arnsten AFT, Huang Y, Carson RE, van Dyck CH. Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging. JAMA Neurol. 2018 Oct 1;75(10):1215-1224. doi: 10.1001/jamaneurol.2018.1836.
PubMed 30014145
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synaptic Vesicle Glycoprotein 2A-PET/CT and PET/MRI Combined Clinical Criteria Score in the Diagnosis of Early Cognitive Alteration
- ClinicalTrials.gov ID
- NCT06445582
- Acronym / sponsor ID
- 2023_ky_390
- Conditions
- Alzheimer Disease
- Keywords
- Molecular Imaging；, Positron Emission Tomography Computed Tomography；, SV2A protein, human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Jun 2024 (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.
Using SV2A-PET to character a cohort of patients with early cognitive impairment using the novel synaptic probe 18F-labeled difluoro-analog of UCB-J（also known as 18F-SDM-8）
Detailed description
A community-based population (Han Chinese) in Hefei, China, based on the CANDI cohort；Single-center prospective case-control study；The projected enrollment population is 80; 40 patients with Alzheimer's Disease（AD）, 30 patients with Mild Cognitive Impairment（MCI）; 10 healthy controls. Diagnostic experiments and predictive prognostic experiments with new probes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CANDI | – | Diagnostic Test: [18F]SDM-8China Aging and Neurodegenerative Initiative |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a single-center prospective exploratory clinical trial, and given this, it is proposed to initially enroll only 80 evaluable subjects (including 40 patients with ALZHEIMER'S DISEASE, 30 patients with MILD COGNITIVE DISABILITY, and 10 age-sex matched non-ALZHEIMER 'S DISEASE controls), each subject underwent 18F-SDM-8 PET/CT imaging, the ability of the tracer to bind to SV2A in the brain as well as non-specific binding, and correlation analysis with changes in relevant clinical indicators to assess the safety and diagnostic efficacy of the tracer.
Key inclusion criteria (12 listed)
- AD Group
- All diagnostic criteria for AD patients met the National Institute of Neurological Speech-Language Disorders Stroke Institute and Alzheimer's Disease and Related Disorders Association criteria;
- Comply with the American Psychiatric Association Diagnostic and Statistical Workbook of Mental Disorders, 5th edition (DSMIV);
- All subjects were unconscious and could be accompanied by behavioral and psychiatric abnormalities. Subjects who meet the above criteria are eligible for enrollment.
- Those who understand the process of this clinical trial and sign the informed consent form (in addition, non-AD volunteers will be recruited through verbal dissemination and posting of paper advertisements to serve as the non-AD control group, and the final control group will be screened by the clinician and consist of healthy people of similar age and gender).
Key exclusion criteria (10 listed)
- With confirmed cerebrovascular disease, the presence of multiple or extensive cerebral infarcts;
- Other types of dementia: Parkinson's disease dementia, vascular dementia, frontotemporal lobe dementia, dementia with Lewy bodies;
- Sudden onset or stroke-like episodes;
- Early onset of focal neurological symptoms, such as hemiparesis, computational deficits, ataxia, or sensory loss;
- Seizures or gait abnormalities early in the onset of the disease;
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]SDM-8synaptic vesicle glycoprotein 2 A（SV2A）PET tracer [18F]SDM-8 | Diagnostic test | CANDI |
Primary outcome
SUVR（Standardized Uptake Value Ratio）
Time frame: 1year
Standardized semi-quantitative values of SUVR for each brain region of the cerebral cortex；Standardized Uptake Value ratio (SUVr) is a metric used to evaluate the results of PET scans of the brain. It is a measure of the extent of abnormal metabolism or abnormal deposits in a brain region by comparing the uptake value of a specific brain region to the uptake values of neighboring regions. SUVr is calculated as follows: 1. first, a reference region is selected, usually an adjacent region of healthy tissue that is unaffected by disease. 2. then, the uptake value for the region of interest (e.g., the brain region), denoted as SUV, is calculated. 3. next, the average uptake value of the reference region, denoted as SUVref, is calculated. 4. finally, the SUVr is calculated, obtained by dividing the SUV of the region of interest by the SUVref of the reference region.
1 secondary outcome
AUC（Area under the curve）of SUVR
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Background: PubMed 26639968Stockburger C, Miano D, Baeumlisberger M, Pallas T, Arrey TN, Karas M, Friedland K, Muller WE. A Mitochondrial Role of SV2a Protein in Aging and Alzheimer's Disease: Studies with Levetiracetam. J Alzheimers Dis. 2016;50(1):201-15. doi: 10.3233/JAD-150687.
- Background: PubMed 8083732Bajjalieh SM, Frantz GD, Weimann JM, McConnell SK, Scheller RH. Differential expression of synaptic vesicle protein 2 (SV2) isoforms. J Neurosci. 1994 Sep;14(9):5223-35. doi: 10.1523/JNEUROSCI.14-09-05223.1994.
- Background: PubMed 35648810Spurrier J, Nicholson L, Fang XT, Stoner AJ, Toyonaga T, Holden D, Siegert TR, Laird W, Allnutt MA, Chiasseu M, Brody AH, Takahashi H, Nies SH, Perez-Canamas A, Sadasivam P, Lee S, Li S, Zhang L, Huang YH, Carson RE, Cai Z, Strittmatter SM. Reversal of synapse loss in Alzheimer mouse models by targeting mGluR5 to prevent synaptic tagging by C1Q. Sci Transl Med. 2022 Jun;14(647):eabi8593. doi: 10.1126/scitranslmed.abi8593. Epub 2022 Jun 1.
- Background: PubMed 26848175Nabulsi NB, Mercier J, Holden D, Carre S, Najafzadeh S, Vandergeten MC, Lin SF, Deo A, Price N, Wood M, Lara-Jaime T, Montel F, Laruelle M, Carson RE, Hannestad J, Huang Y. Synthesis and Preclinical Evaluation of 11C-UCB-J as a PET Tracer for Imaging the Synaptic Vesicle Glycoprotein 2A in the Brain. J Nucl Med. 2016 May;57(5):777-84. doi: 10.2967/jnumed.115.168179. Epub 2016 Feb 4.
- Background: PubMed 32859701Naganawa M, Li S, Nabulsi N, Henry S, Zheng MQ, Pracitto R, Cai Z, Gao H, Kapinos M, Labaree D, Matuskey D, Huang Y, Carson RE. First-in-Human Evaluation of 18F-SynVesT-1, a Radioligand for PET Imaging of Synaptic Vesicle Glycoprotein 2A. J Nucl Med. 2021 Apr;62(4):561-567. doi: 10.2967/jnumed.120.249144. Epub 2020 Aug 28.
- Background: PubMed 30396272Li S, Cai Z, Wu X, Holden D, Pracitto R, Kapinos M, Gao H, Labaree D, Nabulsi N, Carson RE, Huang Y. Synthesis and in Vivo Evaluation of a Novel PET Radiotracer for Imaging of Synaptic Vesicle Glycoprotein 2A (SV2A) in Nonhuman Primates. ACS Chem Neurosci. 2019 Mar 20;10(3):1544-1554. doi: 10.1021/acschemneuro.8b00526. Epub 2018 Nov 16.
- Background: PubMed 30014145Chen MK, Mecca AP, Naganawa M, Finnema SJ, Toyonaga T, Lin SF, Najafzadeh S, Ropchan J, Lu Y, McDonald JW, Michalak HR, Nabulsi NB, Arnsten AFT, Huang Y, Carson RE, van Dyck CH. Assessing Synaptic Density in Alzheimer Disease With Synaptic Vesicle Glycoprotein 2A Positron Emission Tomographic Imaging. JAMA Neurol. 2018 Oct 1;75(10):1215-1224. doi: 10.1001/jamaneurol.2018.1836.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Qiang Xie, PhD principal investigator
University of Sience and Technology of China
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Anhui Provincial Hospital.
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 12 inclusion and 10 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Zehua Zhu, MD (15243611341, zhuzehua2023@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVR（Standardized Uptake Value Ratio） (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06445582, which also lists 7 linked publications.
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 Jun 2024.