Subjective Cognitive DeclinePhase 2NCT03057938
Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study
A Phase 2 study testing 18F-Florbetaben (FBB) in people with Subjective Cognitive Decline, run by Fundacion Clinic per a la Recerca Biomédica.
Trial summary
Phase II, open-label clinical trial with a medicinal product. A total of 30 subjects will be included in the study. All participants will receive a single intravenous dose of 300 MBq of FBB. A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of FBB. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- 18F-Florbetaben (FBB)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Jun 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be committed to participate and complete all study procedures.
- The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
- Age ≥ 60
- Mini-Mental State Examination cutoff for inclusion will be ≥ 26.
- Clinical Dementia Rating <0,5.
- Subjects must have signed the Informed Consent Form voluntarily to participate in the study.
Who cannot join
- Subjects those are not able to complete the study.
- Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ≥ 5 x ULN) or advanced renal insufficiency (creatinine ≥ 2 x ULN).
- Current or previous history of alcohol abuse or epilepsy.
- Allergic to Florbetaben or any of its constituents.
- Multiple drug allergies and/or previous history of contrast allergy.
- Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function).
- Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure.
- Pregnancy or breast feeding or planned pregnancy during the study period.
About this study
Phase II, open-label clinical trial with a medicinal product. A total of 30 subjects will be included in the study.
All participants will receive a single intravenous dose of 300 MBq of FBB. A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of FBB.
The present proposal aims are: to assess safety of a single dose of FBB followed by PET scan in individuals with subjective cognitive decline (SCD), to determine the number of SCD subjects with positive visual FBB-PET scan, to determine the number of SCD subjects with positive standardized uptake value ratios (SUVRs) of FBB-PET scan and to explore the cortical pattern of amyloid deposition in SCD subjects.
Read the detailed description
statistical methods: Primary outcomes For the analysis of the primary outcomes, a descriptive statistical approach will be implemented, calculating the proportion of adverse events and the proportion of SCD subjects that are positive for FBB-PET at visual assessment 9.2 Data Management Demographical and neuropsychological data will be entered in a data base. Statistical analyses will be performed with the SPSS software for Windows (v.22.0).
Sample size A sample size of 30 subjects has been estimated. Since this is a proof-of-concept study, this assumption has been based on previously published data.
Statistical significance and adjustments for multiplicity The analysis will be carried out according to the principles of the ICHE9 Guide and in accordance with the recommendations of CPM/EWP/908/99 Points to Consider on Multiplicity issues in Clinical Trials. The contrast will be carried out with an Error of Type 5 bilateral I. In any case, since this is a exploratory study, there will be no adjustments for multiplicity.
Criteria for discontinuation
The study will be completed when these two premises are met:
- Inclusion of the number of patients needed for the sample size
- End of clinical monitoring No interim analyses are planned.
- Conditions
- Subjective Cognitive Decline
- Being tested
- 18F-Florbetaben (FBB)
- Keywords
- Alzheimer, Subjective Cognitive Decline, Florbetaben
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Florbetaben (FBB)Drug
Also called FBB
All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Florbetaben (FBB) | Experimental | 18F-Florbetaben Receives: Drug: 18F-Florbetaben (FBB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with Subjective Cognitive Decline
Measured: 24 months
Positive visual FBB-PET scan
Proportion of Subjective Cognitive Decline subjects that present positive uptake after FBB-PET through visual examination.
Measured: 24 months
Secondary outcomes (2)
Positive standardized uptake value ratios
Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
Measured: 24 months
Cortical pattern of amyloid deposition
To explore the cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study startJul 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: The sponsor cannot provide the study treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjective Cognitive DeclineStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II, open-label clinical trial with a medicinal product.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Lorena Rami, Dr, Principal investigator, Fundació Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057938
- Sponsor's protocol ID
- Euro-SCD-FBB2
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2017
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study
- ClinicalTrials.gov ID
- NCT03057938
- Acronym / sponsor ID
- Euro-SCD-FBB2
- Conditions
- Subjective Cognitive Decline
- Keywords
- Alzheimer, Subjective Cognitive Decline, Florbetaben
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sponsor cannot provide the study treatment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 20 Feb 2017 (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.
Phase II, open-label clinical trial with a medicinal product. A total of 30 subjects will be included in the study.
All participants will receive a single intravenous dose of 300 MBq of FBB. A 20-minute PET image should be acquired starting at approximately 90 minutes after intravenous injection of FBB.
The present proposal aims are: to assess safety of a single dose of FBB followed by PET scan in individuals with subjective cognitive decline (SCD), to determine the number of SCD subjects with positive visual FBB-PET scan, to determine the number of SCD subjects with positive standardized uptake value ratios (SUVRs) of FBB-PET scan and to explore the cortical pattern of amyloid deposition in SCD subjects.
Detailed description
statistical methods: Primary outcomes For the analysis of the primary outcomes, a descriptive statistical approach will be implemented, calculating the proportion of adverse events and the proportion of SCD subjects that are positive for FBB-PET at visual assessment 9.2 Data Management Demographical and neuropsychological data will be entered in a data base. Statistical analyses will be performed with the SPSS software for Windows (v.22.0).
Sample size A sample size of 30 subjects has been estimated. Since this is a proof-of-concept study, this assumption has been based on previously published data.
Statistical significance and adjustments for multiplicity The analysis will be carried out according to the principles of the ICHE9 Guide and in accordance with the recommendations of CPM/EWP/908/99 Points to Consider on Multiplicity issues in Clinical Trials. The contrast will be carried out with an Error of Type 5 bilateral I. In any case, since this is a exploratory study, there will be no adjustments for multiplicity.
Criteria for discontinuation
The study will be completed when these two premises are met:
- Inclusion of the number of patients needed for the sample size
- End of clinical monitoring No interim analyses are planned.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II, open-label clinical trial with a medicinal product.
| Arm | Type | Receives |
|---|---|---|
| 18F-Florbetaben (FBB) | Experimental | Drug: 18F-Florbetaben (FBB)18F-Florbetaben |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be committed to participate and complete all study procedures.
- The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
- Age ≥ 60
- Mini-Mental State Examination cutoff for inclusion will be ≥ 26.
- Clinical Dementia Rating <0,5.
Key exclusion criteria (8 listed)
- Subjects those are not able to complete the study.
- Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ≥ 5 x ULN) or advanced renal insufficiency (creatinine ≥ 2 x ULN).
- Current or previous history of alcohol abuse or epilepsy.
- Allergic to Florbetaben or any of its constituents.
- Multiple drug allergies and/or previous history of contrast allergy.
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-Florbetaben (FBB)Also: FBBAll participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan. | Drug | 18F-Florbetaben (FBB) |
Primary outcome
Incidence of Adverse Events
Time frame: 24 months
Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with Subjective Cognitive Decline
Positive visual FBB-PET scan
Time frame: 24 months
Proportion of Subjective Cognitive Decline subjects that present positive uptake after FBB-PET through visual examination.
2 secondary outcomes
Positive standardized uptake value ratios
Time frame: 24 months
Cortical pattern of amyloid deposition
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
Lorena Rami, Dr principal investigator
Fundació Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-Florbetaben (FBB) in people with Subjective Cognitive Decline, run by Fundacion Clinic per a la Recerca Biomédica.
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 6 inclusion and 8 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: withdrawn, as of the sponsor's last update on 12 Mar 2025. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Adverse Events (time frame: 24 months). The study lists 2 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 12 Mar 2025.