New study presented at ECPN 2022 finds that vortioxetine improves depressive symptoms and cognitive function in patients with Major Depressive Disorder and co-morbid dementia

Lundbeck A/S (Lundbeck) announced positive data showing Trintellix/Brintellix^® (vortioxetine) significantly reduced depressive symptoms and improved cognitive performance in people living with Major Depressive Disorder (MDD) and co-morbid dementia. This data was presented at the 35^th European College of Neuropsychopharmacology (ECNP) Congress, October 15-18, 2022, in Vienna, Austria.

“MDD is a risk factor for developing dementia, and dementia is an aggravating factor for MDD. Both are clinical conditions with high unmet need and commonly occur as co-morbidities¹,” says Johan Luthman, Executive Vice President, Research and Development at Lundbeck. “We are pleased to share data which reinforces the safety and efficacy of vortioxetine on depressive symptoms and sheds new light on its potential to improve cognitive performance in adults aged 55 and older living with MDD and co-morbid early dementia.”

MEMORY study results met the primary endpoint, showing significant improvement in symptoms of depression as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). MEMORY study results demonstrated a clinically meaningful² reduction of 12.4 points from the baseline to week 12 (p<0.0001).

Secondary endpoints in the study measuring cognitive performance were also met, as shown by significant and clinically relevant improvements in the Digit Symbol Substitution Test (DSST); a measure of attention, working memory, learning ability, and processing speed, and the Rey Auditory Verbal Learning Test (RAVLT); a measure verbal memory. The specific improvement as measured from baseline in standardized effect sizes were:

• Digit Symbol Substitution Test (DSST): Week 4=0.52 (p<0.0001) and Week 12=0.65, p<0.0001
• Rey Auditory Verbal Learning Test (RAVLT) immediate recall: Week 4=0.26, p=0.0361; Week 12=0.28, p=0.0176
• RAVLT delayed recall: Week 4=0.32, p=0.0047; Week 12=0.33, p=0.0062

Significant improvement in patients’ health-related quality of life as measured by the Bath Assessment of Subjective Quality of Life in Dementia (BASQID) was also observed from week four (change from baseline in total score = 4.4; p<0.0001) and increasing in effect until week 12 (change from baseline = 10.2; p<0.0001).

Safety and tolerability data reported in the study were consistent with data from the pivotal development program of vortioxetine, confirming the tolerability profile of the compound.

Depression and dementia commonly co-occur. Depression occurs in approximately 20–30% of patients with Alzheimer’s disease and is even more prevalent in patients with vascular dementia and dementia with Lewy bodies¹. Patients with depressive symptoms have a 1.2–2.4x higher risk of developing dementia than those without depressive symptoms^2-6. The presence of depressive symptoms in dementia worsens patient outcomes, resulting in increased mortality rates,⁷ greater functional impairment,⁸ worse health-related quality of life,⁸ decreased cognitive function⁹ and increased Behavioural and Psychological Symptoms of Dementia¹⁰.

More information about the study and Lundbeck at ECNP 2022 can be viewed here.