Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study
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|ClinicalTrials.gov Identifier: NCT03057938|
Recruitment Status : Unknown
Verified October 2017 by Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica.
Recruitment status was: Not yet recruiting
First Posted : February 20, 2017
Last Update Posted : May 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Subjective Cognitive Decline||Drug: 18F-Florbetaben (FBB)||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase II, open-label clinical trial with a medicinal product.|
|Masking:||None (Open Label)|
|Official Title:||Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||March 15, 2019|
|Estimated Study Completion Date :||March 15, 2019|
Experimental: 18F-Florbetaben (FBB)
Drug: 18F-Florbetaben (FBB)
All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.
Other Name: FBB
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057938
|Contact: Lorena Rami, Dr.||+34 email@example.com|
|Contact: Anna Cruceta||+34 932275400 ext firstname.lastname@example.org|