Treatment of Patients with Mild Cognitive Impairment measuring Brain Function with Functional Magnetic Resonance Imaging

Phase 1

• Conditions: Mild cognitive impairment; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001836-69-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-21
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1.Age 50-80 years
2.Concern regarding a change in cognition by the subject, an informant, or a clinican
3.Objective memory impairment for age and optionally impairment in other cognitive domains
4.Hippocampal volume loss or medial temporal atrophy as evidenced by MRI
5.Sufficient visual and auditory performance for neuropsychological testing
6.Willingness and competence to sign the informed consent form
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous or current DSM-5 axis-I disorder
2.Fulfilment of the criteria for dementia
3.Evidence of previous or current significant neurological disorder
4.Significant medical illness relevant for this study
5.Use of prohibited concomitant medication (see section 9.1.8)
6.Women with childbearing potential
7.Reversible causes for memory impairment
8.Pace makers, cochlear implants, insulin pumps, other implants made of ferromagnetic materials

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To measure the effect of vortioxetine 10mg or 20mg on brain functional connectivity (FC) assessed by functional magnetic resonance imaging (fMRI) and neuropsychological parameters.;Secondary Objective: Not applicable;Primary end point(s): Whole brain functional connectivity;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Scores on the verbal learning test (VLMT) and the digit symbol substitution test (DSST);Timepoint(s) of evaluation of this end point: 12 weeks