Subjects with subjective cognitive decline: 18F-Florbetaben Positrón Emission Tomography Study.

Phase 1

• Conditions: Subjects with subjective cognitive decline.; MedDRA version: 19.0 Level: LLT Classification code 10032831 Term: Other specified non-arthropod-borne viral diseases of central nervous system System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-003451-30-ES
• Lead Sponsor: Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. According to the principal investigator, participants must be committed to participate and complete all study procedures.
2. The patient must report a memory problem (in isolation or in combination with complaints in other domains) with concern.
3. Age >/= 60*.
4. MMSE cutoff for inclusion will be = 26.
5. CDR<0.5.
6. Has signed the Informed Consent Form voluntarily to participate in the study.

* Women of childbearing potential must agree to sexual abstinence, barrier or hormonal contraceptive methods during the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Subjects those are not able to complete the study.
2. 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).
3. Current or previous history of alcohol abuse or epilepsy.
4. Allergic to Florbetaben or any of its constituents.
5. Multiple drug allergies and/or previous history of contrast allergy.
6. 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).
7. Evidence for any other neurological or psychiatric disease, eg. parkinsonism, history of stroke or seizure.
8. Pregnancy or breast feeding or planned pregnancy during the study period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: 1. To assess safety of a single dose of FBB followed by PET scan in individuals with subjective cognitive decline (SCD).<br> 2. To determine the number of SCD subjects with positive visual FBB-PET scan.<br> ;<br> Secondary Objective: 1. To determine the number of SCD subjects with positive standardized uptake value ratios (SUVRs) of FBB-PET scan.<br> 2. To explore the cortical pattern of amyloid deposition in SCD subjects.<br> ;<br> Primary end point(s): 1. Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals with SCD.<br> 2. Proportion of SCD subjects that present positive uptake after FBB-PET through visual examination.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. SUSARs, SAEs, death.<br> 2. Proportion of FBB-PET with positive result through visual examination.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.<br> 2. The cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. Proportion of SCD subjects presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.<br> 2. The cortical pattern of amyloid deposition in SCD subjects at visual and semi-quantitative examination.<br>