drugset / Trial / NCT03272711
Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training
Phase 4
Completed
129 enrolled
Washington University School of Medicine
Queen's University · collabTakeda · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this research study is to examine the potential benefits of vortioxetine in combination with at-home computerized cognitive training program to improve cognition, such as memory, attention, and concentration. This study will compare the effectiveness of vortioxetine plus cognitive training versus placebo plus cognitive training.
Timeline
- Start
- 2016-08-31
- Primary completion
- 2019-01-24
- Completion
- 2019-01-24
Outcome
Met primary endpoint
paper Participants who received vortioxetine with cognitive training showed a greater increase in global cognitive performance compared with those who received placebo with cognitive training. PMID 32212856 ↗
paper This separation was significant at week 12 but not at other assessment time points. PMID 32212856 ↗
Publications
- Background Ball K, Berch DB, Helmers KF, Jobe JB, Leveck MD, Marsiske M, Morris JN, Rebok GW, Smith DM, Tennstedt SL, Unverzagt FW, Willis SL; Advanced Cognitive Training for Independent and Vital Elderly Study Group. Effects of cognitive training interventions with older adults: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2271-81. doi: 10.1001/jama.288.18.2271.
- Background Bowie CR, Gupta M, Holshausen K, Jokic R, Best M, Milev R. Cognitive remediation for treatment-resistant depression: effects on cognition and functioning and the role of online homework. J Nerv Ment Dis. 2013 Aug;201(8):680-5. doi: 10.1097/NMD.0b013e31829c5030.
- Background Kozauer N, Katz R. Regulatory innovation and drug development for early-stage Alzheimer's disease. N Engl J Med. 2013 Mar 28;368(13):1169-71. doi: 10.1056/NEJMp1302513. Epub 2013 Mar 13. No abstract available.
- Background Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.
- Lenze EJ, Stevens A, Waring JD, Pham VT, Haddad R, Shimony J, Miller JP, Bowie CR. Augmenting Computerized Cognitive Training With Vortioxetine for Age-Related Cognitive Decline: A Randomized Controlled Trial. Am J Psychiatry. 2020 Jun 1;177(6):548-555. doi: 10.1176/appi.ajp.2019.19050561. Epub 2020 Mar 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vortioxetine | Unknown | 10 mg | — |