Dementia With Lewy BodiesNCT04154215
FDG Metabolism in Dementia With Lewy Body (DLB) Patients as Indicated by PET Dynamic Acquisition
A study testing PET-CT FDG brain scan in people with Dementia With Lewy Bodies, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population. Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population . Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- PET-CT FDG brain scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2019to 14 Dec 2021
- Phase
- Interventional
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A cohort of healthy patients with no symptoms or family history of DLB will be tested as control group.
- Healthy asymptomatic patients with first-degree relatives of DLB patients.
- DLB patients that went through comprehensive neuropsychological assessments and were confirmed as suffering from DLB.
Who cannot join
- Age <18.
- Pregnant or breath feeding patients.
About this study
Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population.
Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population . This disorder belongs to the family of synucleinopathies, which are diseases characterized by the abnormal accumulation of the protein α-synuclein (α-syn) in neuronal and non-neuronal cells in the brain. The clinical symptoms of DLB include dementia with the presence of fluctuations in attention or alertness, recurrent visual hallucinations, spontaneous extrapyramidal motor features and REM sleep behavior disorder (RBD). Supportive clinical symptoms are severe sensitivity to antipsychotic agents, postural instability, repeated falls, syncope or other transient episodes of unresponsiveness, severe autonomic dysfunction e.g. constipation, orthostatic hypotension, urinary incontinence, hypersomnia, hyposmia, hallucinations in other modalities, systematized delusions, apathy, anxiety and depression. DLB differs from PD by the order of appearance of clinical symptoms.
Read more
The diagnosis of DLB requires in addition to the clinical symptoms the existence biomarkers indicating the pathology. It is important to note that due to the complexity of DLB diagnosis, mainly due to the similarity of this syndrome to other dementia conditions, more than one biomarker is required to identify DLB [6]. The biomarkers contain indicative biomarkers and supportive biomarkers. Indicative biomarkers include a. Assessment of the integrity of dopaminergic system by either F-DOPA Positron Emission Tomography (PET) or by Ioflupane 123I (DaT) Single Photon Emission Tomography (SPECT) scans. b. Abnormal (low uptake) MIBG myocardial scintigraphy. c. Polysomnographic confirmation of REM sleep without atonia.
Supportive biomarkers are: a. MRI/CT scans showing neuronal structural modifications with relative preservation of medial temporal lobe structures. b. Generalized low uptake on SPECT/PET perfusion/metabolism scan with reduced occipital activity +/- the cingulate island sign on 18F-fludeoxyglucose (FDG) PET imaging. c. Prominent posterior slow wave activity on EEG with periodic fluctuations in the pre-alpha/theta range.
Biochemical biomarkers from the blood and spinal fluid were also investigated. These biomarkers include measurement of levels of Amyloid β, tau, and phospho-tau measurements. However, they do not allow differentiation between DLB and AD. α-syn was not proven as a biomarker.
Read the detailed description
The purpose of this research is to assess whether dynamic FDG-PET scans and quantitative analysis of the these scans can give a more accurate and sensitive information regarding the DLB brain glucose metabolism which in turn may give better insight about DLB mechanism and allow better assessment of the disease.
Glucose metabolism in the brains of DLB patients is characterized by a pattern of bilateral parietal and posterior temporal hypometabolism with specific occipital hypo metabolic signature [9]. The use of FDG-PET scans allows the mapping of the topographic hypo metabolic view of the brain in different stages of the DLB condition. These metabolic maps, in turn, can be used both for diagnostic purposes as well as for research of the DLB mechanism [10] [11]. FDG is also a modality assisting in the differentiation between AD, PD and DLB [12]. To notice, the disadvantage of the FDG-PET scans is the lack of quantification. Visually analysis of brain FDG metabolism without quantitative analysis is limiting its use as a biomarker and the diagnostic accuracy and sensitivity of the scan. This is the main reason why it is considered only a supportive biomarker [9].
In these study the investigators will investigate the utilization of dynamic FDG PET scans in order to track in more close and precise way the path of the glucose metabolism in the brain. In addition, the investigators would like to use the dynamic scans to perform quantification of the FDG distribution in the brain in order to show the advantage of the quantification in the diagnostic process.
- Conditions
- Dementia With Lewy Bodies
- Being tested
- PET-CT FDG brain scan
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT FDG brain scanDiagnostic test
Scans will be performed in Discovery MI PET/CT scanner (by GE). Dynamic FDG PET scan start immediately after a bolus injection of 18F-FDG (0.1 mCi/kg) 5. Dynamic PET scan protocol of 30 min will be follow by a static scan protocol with a duration of 8 min combined with a low dose CT scan.
The radiation exposure of the patients is equal to the radiation exposure during the routine PET-CT FDG brain scan. The only discomfort to the patient is a longer scan duration.
After the scan is concluded the patient will be released with no restrictions. Each of the acquired PET images will undergo visual assessment. In addition, quantification of the image data using Standardized Uptake Values (SUV) and kinetic model. The correlation between the clinical information, visual assessment and quantitative parameters will be tested. Sensitivity and accuracy of the quantification methods will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| Dementia with Lewy Body (DLB) patients | Experimental | Not described Receives: Diagnostic Test: PET-CT FDG brain scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients that have shown the tracer time activity curve between healthy, DLB and AD patients for differential diagnosis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start14 Dec 2019 (estimated)
- Primary completion14 Jan 2020 (estimated)
- Study completion14 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154215
- Sponsor's protocol ID
- TASMC-19-ES-0516-CTIL
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG Metabolism in Dementia With Lewy Body (DLB) Patients as Indicated by PET Dynamic Acquisition
- ClinicalTrials.gov ID
- NCT04154215
- Acronym / sponsor ID
- TASMC-19-ES-0516-CTIL
- Conditions
- Dementia With Lewy Bodies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 14 Dec 2019 (estimated)
- Primary completion
- 14 Jan 2020 (estimated)
- Study completion
- 14 Dec 2021 (estimated)
- First posted
- 6 Nov 2019 (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.
Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population.
Dementia with Lewy Body (DLB) is a common neurodegenerative disorder responsible to 15%-20% of the dementia cases in the elderly population . This disorder belongs to the family of synucleinopathies, which are diseases characterized by the abnormal accumulation of the protein α-synuclein (α-syn) in neuronal and non-neuronal cells in the brain. The clinical symptoms of DLB include dementia with the presence of fluctuations in attention or alertness, recurrent visual hallucinations, spontaneous extrapyramidal motor features and REM sleep behavior disorder (RBD). Supportive clinical symptoms are severe sensitivity to antipsychotic agents, postural instability, repeated falls, syncope or other transient episodes of unresponsiveness, severe autonomic dysfunction e.g. constipation, orthostatic hypotension, urinary incontinence, hypersomnia, hyposmia, hallucinations in other modalities, systematized delusions, apathy, anxiety and depression. DLB differs from PD by the order of appearance of clinical symptoms.
The diagnosis of DLB requires in addition to the clinical symptoms the existence biomarkers indicating the pathology. It is important to note that due to the complexity of DLB diagnosis, mainly due to the similarity of this syndrome to other dementia conditions, more than one biomarker is required to identify DLB [6]. The biomarkers contain indicative biomarkers and supportive biomarkers. Indicative biomarkers include a. Assessment of the integrity of dopaminergic system by either F-DOPA Positron Emission Tomography (PET) or by Ioflupane 123I (DaT) Single Photon Emission Tomography (SPECT) scans. b. Abnormal (low uptake) MIBG myocardial scintigraphy. c. Polysomnographic confirmation of REM sleep without atonia.
Supportive biomarkers are: a. MRI/CT scans showing neuronal structural modifications with relative preservation of medial temporal lobe structures. b. Generalized low uptake on SPECT/PET perfusion/metabolism scan with reduced occipital activity +/- the cingulate island sign on 18F-fludeoxyglucose (FDG) PET imaging. c. Prominent posterior slow wave activity on EEG with periodic fluctuations in the pre-alpha/theta range.
Biochemical biomarkers from the blood and spinal fluid were also investigated. These biomarkers include measurement of levels of Amyloid β, tau, and phospho-tau measurements. However, they do not allow differentiation between DLB and AD. α-syn was not proven as a biomarker.
Detailed description
The purpose of this research is to assess whether dynamic FDG-PET scans and quantitative analysis of the these scans can give a more accurate and sensitive information regarding the DLB brain glucose metabolism which in turn may give better insight about DLB mechanism and allow better assessment of the disease.
Glucose metabolism in the brains of DLB patients is characterized by a pattern of bilateral parietal and posterior temporal hypometabolism with specific occipital hypo metabolic signature [9]. The use of FDG-PET scans allows the mapping of the topographic hypo metabolic view of the brain in different stages of the DLB condition. These metabolic maps, in turn, can be used both for diagnostic purposes as well as for research of the DLB mechanism [10] [11]. FDG is also a modality assisting in the differentiation between AD, PD and DLB [12]. To notice, the disadvantage of the FDG-PET scans is the lack of quantification. Visually analysis of brain FDG metabolism without quantitative analysis is limiting its use as a biomarker and the diagnostic accuracy and sensitivity of the scan. This is the main reason why it is considered only a supportive biomarker [9].
In these study the investigators will investigate the utilization of dynamic FDG PET scans in order to track in more close and precise way the path of the glucose metabolism in the brain. In addition, the investigators would like to use the dynamic scans to perform quantification of the FDG distribution in the brain in order to show the advantage of the quantification in the diagnostic process.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia with Lewy Body (DLB) patients | Experimental | Diagnostic Test: PET-CT FDG brain scan |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A cohort of healthy patients with no symptoms or family history of DLB will be tested as control group.
- Healthy asymptomatic patients with first-degree relatives of DLB patients.
- DLB patients that went through comprehensive neuropsychological assessments and were confirmed as suffering from DLB.
Key exclusion criteria (2 listed)
- Age <18.
- Pregnant or breath feeding patients.
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 |
|---|---|---|
| PET-CT FDG brain scanScans will be performed in Discovery MI PET/CT scanner (by GE). Dynamic FDG PET scan start immediately after a bolus injection of 18F-FDG (0.1 mCi/kg) 5. Dynamic PET scan protocol of 30 min will be follow by a static scan protocol with a duration of 8 min combined with a low dose CT scan. The radiation exposure of the patients is equal to the radiation exposure during the routine PET-CT FDG brain scan. The only discomfort to the patient is a longer scan duration. After the scan is concluded the patient will be released with no restrictions. Each of the acquired PET images will undergo visual assessment. In addition, quantification of the image data using Standardized Uptake Values (SUV) and kinetic model. The correlation between the clinical information, visual assessment and quantitative parameters will be tested. Sensitivity and accuracy of the quantification methods will be calculated. | Diagnostic test | Dementia with Lewy Body (DLB) patients |
Primary outcome
number of patients that have shown the tracer time activity curve between healthy, DLB and AD patients for differential diagnosis.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing PET-CT FDG brain scan in people with Dementia With Lewy Bodies, run by Tel-Aviv Sourasky Medical Center.
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 3 inclusion and 2 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 Nov 2019. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients that have shown the tracer time activity curve between healthy, DLB and AD patients for differential diagnosis. (time frame: 1 year). 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 Nov 2019.