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

Effects of Vortioxetine in Mild Cognitive Impairment measured by Functional Magnetic Resonance Imaging - Vortioxetine in MCI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001836-69-AT

Enrollment

Registered

2021-07-21

Start date

2021-09-17

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment

Interventions

Trade Name: Brintellix 10mg Product Name: Vortioxetine Pharmaceutical Form: Capsule, hard INN or Proposed INN: Vortioxetine CAS Number: 508233-74-7 Other descriptive name: VORTIOXETINE HYDROBROMIDE Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Austria

Contacts

Public ContactDepartment of Psychiatry

Medical University of Vienna

+4314040035470

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026