Alzheimer DiseaseNCT06179979
PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.
An observational study of Alzheimer Disease, run by IRCCS San Raffaele.
Trial summary
Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- PET/CT with 11C-PiB
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 17 May 2008to 15 Jul 2008
- 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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Adult patients with neurodegenerative diseases will be included: with mild cognitive disorder, Alzheimer's dementia and early temporal frontal degeneration.
Who may be able to join
- Alzheimer's diagnosis according to the diagnostic criteria in use.
Who cannot join
- current or previous treatments with neuroactive drugs;
- pregnancy or breastfeeding.
About this study
Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study.
The validation in larger groups of patients, and the comparison between the different clinical syndromes included in the spectrum, will allow the diagnostic and prognostic potential of the tracer to be evaluated, with important consequences for the clinical management of patients.
Read more
In particular, the tracer could play a central role in the clinical management of patients with neurodegenerative diseases and cognitive impairment.
Numerous pharmacological trials are currently underway, worldwide, for the validation of anti-amyloid drugs. In the future we could think about early monitoring with imaging of the effectiveness of the treatment.
T he FDG PET technique can be of great help in obtaining relationships between radiation damage to the brain and possibly neurological and neuropsychological deficits associates.
- Conditions
- Alzheimer Disease
- Being tested
- PET/CT with 11C-PiB
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT with 11C-PiBDiagnostic test
Subjects considered suitable will undergo a clinical and neuropsychological evaluation and a PET/CT study with intravenous administration of 11C-PIB.
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/CT with 11C-PiB to characterize amyloid protein deposits in patients with neurodegenerative diseases.
Comparative evaluation of the accumulation of amyloid protein in the various neurodegenerative conditions included with attention to the specificity of the tracer as an element of differential diagnosis.
Measured: 2 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 start17 May 2008
- Primary completion15 Jul 2008
- Study completion15 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- 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
- 60 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
- NCT06179979
- Sponsor's protocol ID
- PET-PIB-1
- 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
- PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.
- ClinicalTrials.gov ID
- NCT06179979
- Acronym / sponsor ID
- PET-PIB-1
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 17 May 2008 (actual)
- Primary completion
- 15 Jul 2008 (actual)
- Study completion
- 15 Jul 2008 (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.
Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study.
The validation in larger groups of patients, and the comparison between the different clinical syndromes included in the spectrum, will allow the diagnostic and prognostic potential of the tracer to be evaluated, with important consequences for the clinical management of patients.
In particular, the tracer could play a central role in the clinical management of patients with neurodegenerative diseases and cognitive impairment.
Numerous pharmacological trials are currently underway, worldwide, for the validation of anti-amyloid drugs. In the future we could think about early monitoring with imaging of the effectiveness of the treatment.
T he FDG PET technique can be of great help in obtaining relationships between radiation damage to the brain and possibly neurological and neuropsychological deficits associates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with neurodegenerative diseases will be included: with mild cognitive disorder, Alzheimer's dementia and early temporal frontal degeneration.
Key inclusion criteria (1 listed)
- Alzheimer's diagnosis according to the diagnostic criteria in use.
Key exclusion criteria (2 listed)
- current or previous treatments with neuroactive drugs;
- pregnancy or breastfeeding.
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 with 11C-PiBSubjects considered suitable will undergo a clinical and neuropsychological evaluation and a PET/CT study with intravenous administration of 11C-PIB. | Diagnostic test | – |
Primary outcome
PET/CT with 11C-PiB to characterize amyloid protein deposits in patients with neurodegenerative diseases.
Time frame: 2 years
Comparative evaluation of the accumulation of amyloid protein in the various neurodegenerative conditions included with attention to the specificity of the tracer as an element of differential diagnosis.
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
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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?
An observational study of Alzheimer Disease, 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 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: 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?
PET/CT with 11C-PiB to characterize amyloid protein deposits in patients with neurodegenerative diseases. (time frame: 2 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.