Subjects With Subjective Cognitive Decline: 18F-Florbetaben Positron

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03057938
Study type	Interventional
Source	Fundacion Clinic per a la Recerca Biomédica
Contact	Lorena Rami, Dr.
Phone	+34 932275430
Email	acruceta@clinic.ub.es
Status	Not yet recruiting
Phase	Phase 2
Start date	August 2018
Completion date	March 15, 2019

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04121728` - Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba	N/A
Active, not recruiting	`NCT03271190` - Impact of a Cognitive Intervention Enriched With Leisure Activities in Persons With Subjective Cognitive Decline	N/A
Recruiting	`NCT06078748` - The Lifestyle Exercise and Diet Trial (LEAD) 2.0	N/A
Recruiting	`NCT06287489` - Effects of Mediterranean Diet on Subjective Cognitive Decline	N/A
Recruiting	`NCT05331144` - Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study)	Phase 2
Completed	`NCT02969460` - Neurotrack Virtual Cognitive Health Study	N/A
Completed	`NCT03495037` - Preventing Cognitive and Functional Decline Among Seniors at Risk	N/A
Recruiting	`NCT06095063` - dTMS for Subjective Cognitive Decline	N/A
Recruiting	`NCT06110858` - Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline	N/A
Active, not recruiting	`NCT04330404` - Effects of Cognitive Strategy Training on Daily Function in People With Subjective Cognitive Decline	N/A
Enrolling by invitation	`NCT03772977` - The Brain Health Champion Study	N/A
Completed	`NCT03236454` - tDCS-enhanced Working Memory Training in Subjective Cognitive Decline	N/A
Not yet recruiting	`NCT06358404` - Developing a Peer Support Intervention for Depression in SCD	N/A
Completed	`NCT04796415` - DEMA-Pro Intervention for Seniors With Subjective Cognitive Decline and Living at Home	N/A
Completed	`NCT04439500` - Effects of Online Training Aimed at Increasing Participation in Everyday Life During a Pandemic (SCD Online).	N/A
Completed	`NCT04880252` - Neuropsychological Indicators of SCD Progression
Completed	`NCT04265378` - Cognitive Training and Brain Stimulation in Prodromal Alzheimer's Disease	N/A
Completed	`NCT03370744` - Prediction of Cognitive Decline by Neuroimaging Techniques and the Application in Diagnosis and Treatment of Preclinical AD
Recruiting	`NCT06335836` - The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD)
Not yet recruiting	`NCT05225181` - Effects of the Combining Physical Exercise and Cognitive Training for the Community-based Elderly	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms