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Age-related Cognitive DeclinePhase 4BBSNCT03272711

Remediation of Age-related Cognitive Decline: Vortioxetine and Cognitive Training

A Phase 4 study testing Vortioxetine 10 mg and Cognitive training program in people with Age-related Cognitive Decline, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Age-related Cognitive Decline
What is being tested?
Vortioxetine 10 mg and Cognitive training program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
1 siteUnited States
Study dates
31 Aug 2016to 24 Jan 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Community-living men and women age 65 and older
  • Age-related cognitive decline as defined by (a) self-reported cognitive dysfunction that is attributed to the aging process (in response to screening questions to the participant); (b) ability to complete cognitive battery, but still scoring less than 1 standard deviation above age-matched norms at both baseline and after the two-week cognitive training lead-in.

Who cannot join

  • Known dementia or other clinical neurodegenerative illness (e.g., Parkinson's disease, cerebrovascular disease) per self-report, informant report, medical records, or neuropsychological testing
  • Any current psychiatric disorder
  • Medical conditions that suggest shortened lifespan, such as metastatic cancer; or would prohibit safe participation in the interventions, including cardiovascular disease or musculoskeletal conditions; or with the assessments.
  • Sensory impairment that would prevent participation
  • IQ < 70 as estimated by the Wechsler Test of Adult Reading
  • Alcohol or substance abuse within 6 months
  • Concurrent cognitive training, such as brain-training software, or other interventions expected to affect neuroplasticity
  • Psychotropic medications or those with likely CNS effects (none within 4 weeks prior to study entry)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Read the detailed description

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.

Vortioxetine is considered investigational when used as a treatment for age-related cognitive decline, which means that it has not been approved by the U.S. Food and Drug Administration for this purpose. Vortioxetine is approved by the U.S. Food and Drug Administration as a treatment for depression, and also goes by the name Trintellix (formerly known as Brintellix). That means that, while the drug itself is approved by the FDA, it is not approved for the reasons the investigators are using it in this study.

Participation in this study entails an estimated 6 study visits over the course of approximately six months. Participants will complete various assessments at our lab at the Washington University School of Medicine along with check-in visits in-person or over the phone. Additionally, they will participate in at home computerized cognitive training for approximately six months, supplemented with either vortioxetine or placebo.

The investigators will assess memory and problem-solving abilities using paper and pencil, computerized measures, and self-assessments of how participants feel. These tests could include numbers, letters, symbols, words, or sentences. These tests will be repeated throughout the study. If eligible to do so, participants will complete a baseline MRI scan.

A subset of participants who completed a baseline MRI scan will complete another MRI scan after approximately 26 weeks of vortioxetine or placebo and at home computerized cognitive training.

Being tested
Vortioxetine 10 mg, Cognitive training program
Keywords
Vortioxetine, Elderly, Online cognitive training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vortioxetine 10 mgDrug

    Also called Trintellix

  • Cognitive training programBehavioural

    Online training program, 30 minutes a day, 5 times a week

Study groups in NCT03272711
Study groupRoleWhat they receive
Vortioxetine plus cognitive trainingExperimentalVortioxetine (10 mg) plus cognitive training 5 times weekly for 30 minutes a day
Receives: Drug: Vortioxetine 10 mg; Behavioral: Cognitive training program
Placebo plus cognitive trainingPlacebo comparatorPlacebo plus cognitive training 5 times weekly for 30 minutes a day
Receives: Behavioral: Cognitive training program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Total Fluid Cognitive Score

    Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.

    Measured: Randomization (0 weeks), 4 weeks

Secondary outcomes (2)

  1. Change in Total Fluid Cognitive Score

    Total fluid cognitive score from the NIH Toolbox as well as the speed of cognitive improvement The study utilized five cognitive tests from the NIH Toolbox Cognitive Battery that measured "fluid" cognition-the capacity for new learning and information processing. A higher score indicates indicates better performance on these tests. A total fluid cognitive score at or near 100 indicates ability that is average compared with others nationally. Scores around 115 suggest above-average fluid cognitive ability, while scores around 130 suggest superior ability. Conversely, a score around 85 suggests below-average fluid cognitive ability, and a score in the range of 70 or below suggests significant impairment.

    Measured: Randomization (0 weeks), 4 week, 12 week, 26 week

  2. Participant Function

    Participant function assessed using the UCSD Performance-Based Skills Assessment (UPSA).

    A validated test that required participants to demonstrate their competence to perform everyday functioning tasks in domains such as comprehension, planning, finances, transportation and communication. A higher scores indicates a better outcome. Scores can range from a minimum of 0 to a maximum of 100.

    Measured: Randomization (0 weeks), 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2017
  2. Study start31 Aug 2016
  3. Primary completion24 Jan 2019
  4. Study completion24 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03272711
Sponsor's protocol ID
201509107
Acronym
BBS
Status last verified
Dec 2019
First submitted
1 Sep 2017
Last updated
14 Jan 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 12425704

  • 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.

    PubMed 23896849

  • 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.

    PubMed 23484795

  • 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.

    PubMed 25405755

  • 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.

    PubMed 32212856

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vortioxetine 10 mg and Cognitive training program in people with Age-related Cognitive Decline, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Fluid Cognitive Score (time frame: Randomization (0 weeks), 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03272711, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.

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