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

Primary Purpose

Subjective Cognitive Decline

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

18F-Florbetaben (FBB)

About this trial

This is an interventional prevention trial for Subjective Cognitive Decline focused on measuring Alzheimer, Subjective Cognitive Decline, Florbetaben

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-Florbetaben (FBB)

Arm Description

18F-Florbetaben

Outcomes

Primary Outcome Measures

Incidence of Adverse Events

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

Proportion of Subjective Cognitive Decline subjects that present positive uptake after FBB-PET through visual examination.

Secondary Outcome Measures

Positive standardized uptake value ratios

Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.

Cortical pattern of amyloid deposition

To explore the cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.

Full Information

NCT ID

NCT03057938

First Posted

February 15, 2017

Last Updated

May 22, 2018

Sponsor

Fundacion Clinic per a la Recerca Biomédica

1. Study Identification

Unique Protocol Identification Number

NCT03057938

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2018 (Anticipated)

Primary Completion Date

March 15, 2019 (Anticipated)

Study Completion Date

March 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fundacion Clinic per a la Recerca Biomédica

4. Oversight

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.

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subjective Cognitive Decline

Keywords

Alzheimer, Subjective Cognitive Decline, Florbetaben

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Phase II, open-label clinical trial with a medicinal product.

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

18F-Florbetaben (FBB)

Arm Type

Experimental

Arm Description

18F-Florbetaben

Intervention Type

Drug

Intervention Name(s)

18F-Florbetaben (FBB)

Other Intervention Name(s)

FBB

Intervention Description

All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.

Primary Outcome Measure Information:

Title

Incidence of Adverse Events

Description

Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with Subjective Cognitive Decline

Time Frame

24 months

Title

Positive visual FBB-PET scan

Description

Proportion of Subjective Cognitive Decline subjects that present positive uptake after FBB-PET through visual examination.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Positive standardized uptake value ratios

Description

Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.

Time Frame

24 months

Title

Cortical pattern of amyloid deposition

Description

To explore the cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lorena Rami, Dr.

Phone

+34 932275430

acruceta@clinic.ub.es

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Cruceta

Phone

+34 932275400

Ext

4380

acruceta@clinic.ub.es

12. IPD Sharing Statement

Learn more about this trial

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

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