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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

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.


Condition or disease Intervention/treatment Phase
Subjective Cognitive Decline Drug: 18F-Florbetaben (FBB) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Phase II, open-label clinical trial with a medicinal product.
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-Florbetaben (FBB)
18F-Florbetaben
Drug: 18F-Florbetaben (FBB)
All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.
Other Name: FBB




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Lorena Rami, Dr. +34 932275430 acruceta@clinic.ub.es
Contact: Anna Cruceta +34 932275400 ext 4380 acruceta@clinic.ub.es

Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
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Responsible Party: Anna Cruceta, Project Manager, Fundacion Clinic per a la Recerca Biomédica
ClinicalTrials.gov Identifier: NCT03057938    
Other Study ID Numbers: Euro-SCD-FBB2
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica:
Alzheimer
Subjective Cognitive Decline
Florbetaben
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders