Neurodegenerative DiseasesNCT06180213
Study of Cerebral Glucose Metabolism in Neurodegenerative Diseases and Head Trauma
An observational study of Neurodegenerative Diseases, run by IRCCS San Raffaele.
Trial summary
The reason why each specific degenerative disease is characterized by a different FDG PET pattern is still unclear today. There are four main hypotheses proposed to explain this selective vulnerability: 1) Nodal stress, theory according to which the main nodes of specific brain networks undergo wear and tear, 2)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- FDG PET
- How many people
- 1,570 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 31 Dec 2019
- 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 years and older
- All sexes
- Adult, Older adult
Study population: patients suffering from various forms of Alzheimer's dementia, Parkinsonism, ALS, motor neuron diseases.
Who may be able to join
- presence of diagnosis of neurodegenerative disease.
Who cannot join
- patients< 18 years
About this study
Official title: Study of Cerebral Glucose Metabolism in Neurodegenerative Diseases and Head Trauma: Retrospective Review of an Large Cohort of FDG PET Data
The reason why each specific degenerative disease is characterized by a different FDG PET pattern is still unclear today. There are four main hypotheses proposed to explain this selective vulnerability: 1) Nodal stress, theory according to which the main nodes of specific brain networks undergo wear and tear, 2) trans-neuronal diffusion, theory according to which some toxic agents/proteins or altered propagate along network connections through "Prion-like" mechanisms, 3) trophic failure, in which the interruption of inter-modal connectivity causes the loss of collateral trophic factors, and finally 4) shared vulnerability in which regions also distant from each other are part of a common network which gives a susceptibility uniformly distributed throughout the network.
FDG PET provides in-vivo information on the distribution of brain synaptic dysfunction prior to complete neural death, and represents the main in vivo biomarker of neural dysfunction associated with different clinical conditions characterized by neurodegeneration phenomena. For this reason, FDG PET is considered a fundamental approach to shed light on the causes of selective brain vulnerability in various pathological conditions.
- Conditions
- Neurodegenerative Diseases
- Being tested
- FDG PET
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PETDiagnostic test
Distribution pattern of the FDG tracer in patients with neurodegenerative diseases and identify the regions of altered brain function specific for each clinical condition.
What is being measured
The primary outcome is the main question the study is designed to answer.
FDG PET to measure brain areas of hypo or hyper regional metabolism in patients with neurodegenerative disease.
Characterization of the different pathologies examined starting from the study of regional metabolism in individual subjects up to the study of the functional activity of the different brain circuits.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start1 Oct 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Retrospective
- Enrolment
- 1,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180213
- Sponsor's protocol ID
- FDG-PET
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 22 Dec 2023
- 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 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cerebral Glucose Metabolism in Neurodegenerative Diseases and Head Trauma: Retrospective Review of an Large Cohort of FDG PET Data
- ClinicalTrials.gov ID
- NCT06180213
- Acronym / sponsor ID
- FDG-PET
- Conditions
- Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,570 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Dec 2023 (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.
The reason why each specific degenerative disease is characterized by a different FDG PET pattern is still unclear today. There are four main hypotheses proposed to explain this selective vulnerability: 1) Nodal stress, theory according to which the main nodes of specific brain networks undergo wear and tear, 2) trans-neuronal diffusion, theory according to which some toxic agents/proteins or altered propagate along network connections through "Prion-like" mechanisms, 3) trophic failure, in which the interruption of inter-modal connectivity causes the loss of collateral trophic factors, and finally 4) shared vulnerability in which regions also distant from each other are part of a common network which gives a susceptibility uniformly distributed throughout the network.
FDG PET provides in-vivo information on the distribution of brain synaptic dysfunction prior to complete neural death, and represents the main in vivo biomarker of neural dysfunction associated with different clinical conditions characterized by neurodegeneration phenomena. For this reason, FDG PET is considered a fundamental approach to shed light on the causes of selective brain vulnerability in various pathological conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients suffering from various forms of Alzheimer's dementia, Parkinsonism, ALS, motor neuron diseases.
Key inclusion criteria (1 listed)
- presence of diagnosis of neurodegenerative disease.
Key exclusion criteria (1 listed)
- patients< 18 years
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 |
|---|---|---|
| FDG PETDistribution pattern of the FDG tracer in patients with neurodegenerative diseases and identify the regions of altered brain function specific for each clinical condition. | Diagnostic test | – |
Primary outcome
FDG PET to measure brain areas of hypo or hyper regional metabolism in patients with neurodegenerative disease.
Time frame: 4 years
Characterization of the different pathologies examined starting from the study of regional metabolism in individual subjects up to the study of the functional activity of the different brain circuits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Neurodegenerative Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
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
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
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?
An observational study of Neurodegenerative Diseases, run by IRCCS San Raffaele.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FDG PET to measure brain areas of hypo or hyper regional metabolism in patients with neurodegenerative disease. (time frame: 4 years). 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 22 Dec 2023.