- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03057938
Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Lorena Rami, Dr.
- Phone Number: +34 932275430
- Email: acruceta@clinic.ub.es
Study Contact Backup
- Name: Anna Cruceta
- Phone Number: 4380 +34 932275400
- Email: acruceta@clinic.ub.es
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18F-Florbetaben (FBB)
18F-Florbetaben
|
All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive standardized uptake value ratios
Time Frame: 24 months
|
Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
|
24 months
|
Cortical pattern of amyloid deposition
Time Frame: 24 months
|
To explore the cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Euro-SCD-FBB2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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