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MEMORY

CompletedPhase 4

Vortioxetine in Patients With Depression and Early Dementia

Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia

Lead sponsor

H. Lundbeck A/S

Asset

Vortioxetine

Listed sites

24

Recruiting sites

-

Enrollment

82

actual

Study population

Mixed / unspecified dementia

Key I/E criterion

•MMSE 20-24

Primary endpoint

•Montgomery and Åsberg Depression Rating Scale (MADRS) total score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID18315A
NCT IDNCT04294654

Timeline

Milestones

Study start2020-02-28actual
Study first posted2020-03-04actual
Primary completion2022-07-06actual
Study completion2022-07-20actual
Last update posted2022-08-08actual

Assets

Drug assets

Vortioxetine

Study populations

Who this study enrolls

Mixed / unspecified dementia

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•The patient has a primary diagnosis of recurrent Major Depressive Disorder (MDD) with onset before age of 55, diagnosed according to DSM-5®
•The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
•The patient has had the current MDE for <6 months.
•The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Baseline Visit.
•The diagnosis of onset of dementia has occurred at least 6 months prior to screening and after already being diagnosed with MDD. The diagnosis of dementia must be documented in patient's medical records. When deemed necessary per investigator judgement of patient clinical status and early dementia, the patient must be accompanied by a caregiver to study visits.
•Patients with dementia associated with vitamin B12 or folate deficiency should not be enrolled.
•Patients with or without treatment for dementia can be enrolled. For patients on treatment for dementia, there must be no change in treatment during the study and patients must be on stable dose for at least 3 months prior to the Screening Visit.
•The patient has Mini Mental State Examination (MMSE) total score 20-24, inclusive

Exclusion criteria

The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.

Other in- and exclusion criteria may apply

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
2
Other (unclassified)
2
Memory
1
Executive function / language
1
Function / daily living
1
Behavior / neuropsychiatric
1
Caregiver / quality of life
1

Memory

1 endpoint
Secondary/protocol endpoint

Change in Rey Auditory Verbal Learning Test (RAVLT) score

Time frame:from baseline to Week 12

change from baseline, improvement

Executive function / language

1 endpoint
Secondary/protocol endpoint

Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score

Time frame:from baseline to Week 12

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change in Instrumental Activities of Daily Living (IADL) score

Time frame:from baseline to Week 12

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Primary/protocol endpoint

Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score

Time frame:from baseline to Week 12

change from baseline, improvement

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score

Time frame:from baseline to Week 12

change from baseline, improvement

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Change in Clinical Global Impression - Severity (CGI-S) score

Time frame:from baseline to Week 12

change from baseline, improvement

Secondary/protocol endpoint

Clinical Global Impression - Improvement (CGI-I) score

Time frame:at Week 12

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Response defined by decrease in MADRS total score

Time frame:At Week 12

descriptive

Secondary/protocol endpoint/low confidence

Remission defined by MADRS score

Time frame:at Week 12

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.