Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study

Subjective Cognitive Decline Clinical Trial

Official title:

Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron Emission Tomography Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03057938
• Other study ID #: Euro-SCD-FBB2
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: October 2017
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Lorena Rami, Dr.
• Phone: +34 932275430
• Email: acruceta[@]clinic.ub.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Subjective Cognitive Decline

Intervention

Drug:
• 18F-Florbetaben (FBB)
All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with Subjective Cognitive Decline	24 months
Primary	Positive visual FBB-PET scan	Proportion of Subjective Cognitive Decline subjects that present positive uptake after FBB-PET through visual examination.	24 months
Secondary	Positive standardized uptake value ratios	Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.	24 months
Secondary	Cortical pattern of amyloid deposition	To explore the cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.	24 months